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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4647 | Verinurad Wiki | 0.42 |
| drug277 | Allopurinol Wiki | 0.42 |
| drug5175 | rHuEPO Wiki | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4604 | VB119 Wiki | 0.24 |
| drug2186 | Intervention-EDI and health coaching Wiki | 0.24 |
| drug3734 | Roxadustat Wiki | 0.24 |
| drug1250 | Dapagliflozin 10 mg Wiki | 0.24 |
| drug4668 | Virtual Assistant first, then Human Coach Wiki | 0.24 |
| drug2893 | Nutrition education Wiki | 0.24 |
| drug1261 | Data collection and clinical testing of subjects Wiki | 0.24 |
| drug1131 | Control-EDI Wiki | 0.24 |
| drug1190 | Covid-19 PCR , IGM Wiki | 0.24 |
| drug1248 | Dapagliflozin Wiki | 0.24 |
| drug2291 | LNP023 Wiki | 0.24 |
| drug1572 | Exercise training group Wiki | 0.24 |
| drug1935 | Human Coach first, then Virtual Assistant Wiki | 0.24 |
| drug3693 | Rifampicin Wiki | 0.17 |
| drug189 | AZD9977 Wiki | 0.17 |
| drug178 | AZD5718 Wiki | 0.17 |
| drug3131 | Pentoxifylline Wiki | 0.14 |
| drug1238 | DWRX2003 Wiki | 0.14 |
| drug2453 | MEDI3506 Wiki | 0.14 |
| drug1569 | Exercise program Wiki | 0.14 |
| drug502 | BI 764198 Wiki | 0.14 |
| drug531 | BNT162b2 Wiki | 0.12 |
| drug1213 | Cyclosporine Wiki | 0.11 |
| drug3195 | Placebo Wiki | 0.08 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D051436 | Renal Insufficiency, Chronic NIH | 0.77 |
| D003928 | Diabetic Nephropathies NIH | 0.34 |
| D000740 | Anemia NIH | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D005922 | Glomerulonephritis, IGA NIH | 0.24 |
| D015433 | Glomerulonephritis, Membranous NIH | 0.24 |
| D007676 | Kidney Failure, Chronic NIH | 0.20 |
| D002908 | Chronic Disease NIH | 0.13 |
| D006333 | Heart Failure NIH | 0.12 |
| D007154 | Immune System Diseases NIH | 0.10 |
| D051437 | Renal Insufficiency, NIH | 0.08 |
| D000073496 | Frailty NIH | 0.08 |
| D006973 | Hypertension NIH | 0.05 |
| D008171 | Lung Diseases, NIH | 0.04 |
| D002318 | Cardiovascular Diseases NIH | 0.04 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000077 | Abnormality of the kidney HPO | 1.00 |
| HP:0012622 | Chronic kidney disease HPO | 0.77 |
| HP:0001903 | Anemia HPO | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000794 | IgA deposition in the glomerulus HPO | 0.24 |
| HP:0012578 | Membranous nephropathy HPO | 0.24 |
| HP:0001635 | Congestive heart failure HPO | 0.12 |
| HP:0000083 | Renal insufficiency HPO | 0.08 |
| HP:0000822 | Hypertension HPO | 0.05 |
| HP:0002088 | Abnormal lung morphology HPO | 0.04 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.04 |
Navigate: Correlations HPO
There are 17 clinical trials
Pentoxifylline (PTX) is a medication that has been on the market since 1984 for use in disease in the blood vessels of the legs. There is some preliminary information that it may protect the kidneys from damage due to diabetes and other diseases. "Pentoxifylline in Diabetic Kidney Disease" is a study to bee conducted in 40 VA hospitals across the nation to determine definitively whether or not PTX can prevent worsening of kidney disease and delay death in patients with diabetic kidney disease.
Description: ESRD will be defined as need for chronic dialysis or renal transplantation.
Measure: Time to ESRD or death Time: 5 to 9 yearsDescription: Quality of life as measured by the Kidney Disease Quality of Life Short Form (KDQoL-SF)
Measure: Quality of life (KDQoL-SF) Time: 5 to 9 yearsDescription: Time until doubling of serum creatinine
Measure: Time until doubling of serum creatinine Time: 5 to 9 yearsDescription: The risk of a CHF hospitalization will be based on the participant-time data, specifically, the number of events per years.
Measure: Incidence of congestive heart failure hospitalization (CHF) Time: 5 to 9 yearsDescription: The risk of a MACE event will be based on participant-time data, specifically, the number of events per participant years.
Measure: Incidence of a three-point MACE Time: 5 to 9 yearsDescription: The risk of a PVD event will be based on participant-time data, specifically, the number of events per participant years.
Measure: Incidence of a peripheral vascular disease (PVD) Time: 5 to 9 yearsDescription: Percentage of participants with 50% reduction in UACR from baseline
Measure: Percentage of participants with 50% reduction in UACR from baseline Time: 5 to 9 yearsDescription: Rate of change in eGFR per year during the study period.
Measure: Rate of change in eGFR per year during the study period Time: 5 to 9 yearsChronic kidney disease (CKD) is a serious and growing public health problem. The purpose of this study is to find out if an educational worksheet, called the Encounter Decision Intervention (EDI), combined with health coaching helps CKD patients improve their blood pressure and other health outcomes. The research team hypothesizes that the intervention group will have greater improvement in CKD outcomes than the control group.
Description: Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Measure: Change in Systolic Blood Pressure between baseline and 12 months Time: Baseline, 12 monthsDescription: Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Measure: Change in Diastolic Blood Pressure between baseline and 12 months Time: Baseline, 12 monthsDescription: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Measure: Slope of systolic BP between baseline and 12 months using all available BP values Time: Baseline up to 12 monthsDescription: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Measure: Slope of diastolic BP between baseline and 12 months using all available BP values Time: Baseline up to 12 monthsDescription: This is a 28-item questionnaire measuring objective CKD disease knowledge and includes questions about goals, cardiovascular risk, and anti-hypertensive medications. Patients will answer the questions with a yes or no answer and their score will be based on how many responses were correct. This number will be converted to a percentage.
Measure: CKD knowledge measured by the Kidney Knowledge Survey (KiKS) Time: Baseline up to 12 monthsDescription: This is a 13-item measure with the answers on a Likert scale of 1 (not at all sure) to 4 (extremely sure). The higher the score the higher the self-efficacy, with a range from 13-52.
Measure: Medication Adherence Self-Efficacy Scale-Revised (MASES-R) Time: Baseline up to 12 monthsDescription: This scale is to quantify adherence to pharmacological treatments by means of 8 items. Patients will answer yes or no to these items, where a no response = 1 point and a yes response = 0 points. Levels of adherence are based on the following scores: 3-8 = low adherence; 1-2 = medium adherence; 0 = high adherence.
Measure: Morisky Medication Adherence Scale (MMAS - 8) Time: Baseline up to 12 monthsDescription: Length of time provider spends with the patient. This will be compared between the intervention group and control group.
Measure: Visit Time with provider Time: Enrollment visit (baseline)Description: Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.
Measure: Total time in clinic Time: Enrollment visit (baseline)Description: This contains a 17-item questionnaire in which the participants select scores from 1-7 or does not apply. A number of 1 = not at all and a score of 7 = considered very true, and zero = not applicable.
Measure: Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ) Time: Baseline up to 12 monthsDescription: This is a 15-item questionnaire that assesses the quality of physician to patient communication completed by the patients. There are 5 answers to choose from; poor, fair, good, very good, and excellent. The Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.
Measure: Satisfaction with CKD care based on Communication Assessment Tool (CAT) Time: Baseline up to 12 monthsDescription: This is a 21-item questionnaire that is completed by the patients, and select from the the 4 choices: very strongly agree, strongly agree, agree, and neutral/disagree. Each answer is worth one point on a Likert scale with a higher score meaning more satisfied.
Measure: Satisfaction with CKD care based on Consultation Care Measure (CCM) Time: Baseline up to 12 monthsDescription: During health coach phone calls, participants will be asked 37 questions about their perceptions of the health coach program, including how much their participation in CHECK-D helped participants change various behaviors. Participant responses will be used to examine various measures of reliability and validity during the analyses of data acquired though this survey.
Measure: Perceptions of health coaching for the intervention group Time: Baseline up to 12 monthsDescription: The EMR will be reviewed to evaluate the patients medication refills for adherence.
Measure: Medication adherence from the electronic medical record (EMR) Time: Baseline up to 12 monthsDescription: This is an 8-item scale regarding self-efficacy where each statement is rated on the level of agreement from 1-5. 1 is disagree and 5 is agree.
Measure: Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS) Time: Baseline up to 12 monthsDescription: This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.
Measure: Self-reported Blood Pressure-Related Behaviors Survey Time: Baseline up to 12 monthsDescription: Provider adoption will be measured by the percentage of enrolled patients whose providers used the EDI with them during their visit. Data will be collected by EMR query and a 1-item question in the patient survey.
Measure: Provider Adoption based on EMR query and patient survey Time: BaselineDescription: Provider fidelity will be measured by the percentage of enrolled patients in the intervention clinics whose providers entered 1-2 patient specific goals in the EDI. This will be collected through EMR query.
Measure: Provider Fidelity measured by EMR query Time: BaselineDescription: Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.
Measure: Provider Perception of Usefulness by provider survey Time: Baseline up to 12 monthsDescription: Change in Serum Creatinine between baseline and 12-months
Measure: Change in serum creatinine Time: Baseline, 12 monthsA Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Description: Change compared to placebo
Measure: Urine albumin:creatinine ratio (UACR) Time: Baseline to Day 169 (24 weeks)Description: To assess the number Treatment Emergent Adverse events (TEAEs), Serious Adverse Events (SAEs), Treatment Emergent Adverse Events of Special Interest (AESIs)
Measure: Safety and Tolerability by assessment of adverse events Time: Visit 1 (Screening) to Day 230 (End of Study)Description: MEDI3506 serum PK concentrations throughout the study
Measure: PK profile of MEDI3506 Time: Day 1 to Day 230Description: Anti-drug antibodies (ADAs) incidence throughout the study
Measure: Immunogenicity of MEDI3506 Time: Day 1 to Day 230Description: Proportion of subjects with > 30%, 40% or 50% reduction
Measure: UACR Time: At Day 169, baseline to Day 85 (12 weeks) or Day 85 to Day 169Description: To assess systolic and diastolic blood pressure, heart rate, respiratory rate, temperature, 12-lead electrocardiogram, echocardiogram and physical exam
Measure: Safety and tolerability by assessment of vital signs Time: Visit 1(Screening) to End of studyDescription: To assess hematology, serum chemistry, urinalysis
Measure: Safety and tolerability by clinical laboratory evaluations Time: Visit 1(Screening) to End of studyThe main objective of this trial is to investigate the influence of moderate and severe renal impairment on the pharmacokinetics of a single dose of BI 764198 in comparison to a group of matched controls with normal renal function.
This study will be conducted to investigate the safety of verinurad in healthy volunteers in combination with allopurinol 300 mg, compared with placebo in particular its effect on electrocardiogram (ECG), with focus on the QT/QTc interval
Description: To assess the effect of a single dose of verinurad given as either a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supra-therapeutic exposure), both in combination with allopurinol 300 mg, on the QTcF interval compared to placebo using a concentration-QTcF interval analysis
Measure: Maximum observed plasma concentration (Cmax) Time: Visit 2,3,4:- Day 1: Pre-dose, 0.5,1,1.5,2, 3, 4, 5, 6, 7, 8 and 12 hours post-dose; Day 2: 24 and 36 hours post-dose; Day 3: 48 hours post-doseDescription: To assess the effect of a single dose of verinurad given as either a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supra-therapeutic exposure), both in combination with allopurinol 300 mg, on the QTcF interval compared to placebo using a concentration-QTcF interval analysis
Measure: Baseline-corrected and placebo-adjusted QTcF interval (ΔΔQTcF) Time: Screening; Visit 2,3,4:- Day -1, 1,2, 3; Follow up visit (7 to 10 days after the last dose)Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation(supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected heart rate (ΔHR) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted heart rate (ΔΔHR) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected RR interval (ΔRR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted RR interval (ΔΔRR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected PR interval (ΔPR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted PR interval (ΔΔPR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QRS interval (ΔQRS interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QRS interval (ΔΔQRS interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected QT interval (ΔQT interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QT interval (ΔΔQT interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected QTcF interval (ΔQTcF interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QTcF interval (ΔΔQTcF interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To assess the pharmacokinetics (PK) of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Area under plasma concentration-time curve from zero to infinity (AUC) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects.
Measure: Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC0-t) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Maximum observed plasma concentration (Cmax) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Time to reach maximum observed plasma concentration (tmax) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Time delay between drug administration and the first observed concentration in plasma (tlag) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Time of last quantifiable plasma concentration (tlast) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Apparent total body clearance of drug from plasma after extravascular administration (parent drug only) [CL/F] Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Apparent volume of distribution during the terminal phase after extravascular administration (parent drug only) [Vz/F] Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Apparent volume of distribution at steady state (Vss/F) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess clinical chemistry/hematology/urinalysis as a variable of safety and tolerability of verinurad and allopurinol
Measure: Number of subjects with abnormal haematology, clinical chemistry and urinalysis Time: Screening; Visit 2,3 and 4:- Day -1, Day 3: 48 h post-dose, Follow up periodDescription: To assess vital signs as a variable of safety and tolerability of verinurad and allopurinol
Measure: Number of subjects with abnormal blood pressure and pulse rate Time: Screening; Visit 2,3 and 4:- Day -1, Day 1: pre-dose, 1 and 6 h post-dose; Day 2: 24 h post-dose; Day 3: 48 h post-dose, Follow up visitTo understand the impact of COVID-19 restrictions on the wellbeing, quality of life and physical activity of people with end-stage renal disease, currently dialysing in-centre versus at home in the UK and their experience of telemedicine.
Description: Participants will be asked during a qualitative interview about the effect of COVID-19 restrictions on their; well-being, quality of life and physical activity and sedentary behaviours
Measure: Qualitative assessment of the effect of COVID-19 restrictions on patients' well-being, quality of life and physical activity and sedentary behaviours Time: Day 1Description: Participants will be asked during a qualitative interview about their perceptions and experiences of telemedicine
Measure: Thematic analysis of qualitative interview exploring patients' experiences of telemedicine during the COVID-19 restrictions in the UK Time: Day 1Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.
Description: Semi structured interview
Measure: Safety and efficacy of a home-based exercise training program Time: From baseline to 3 months of follow-upDescription: Semi structured interview
Measure: Patients perceptions during social isolation Time: From baseline to 3 months of follow-upDescription: Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
Measure: Adolescents quality of life Time: From baseline to 3 months of follow-upDescription: Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
Measure: Disease activity Time: From baseline to 3 months of follow-upDescription: Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
Measure: Disease overall assessment Time: From baseline to 3 months of follow-upDescription: Will be assessed by means of Strengths & Difficulties Questionnaires
Measure: Strengths and difficulties Time: From baseline to 3 months of follow-upThe coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions. In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.
Description: Meeting of at least one of the modified KDIGO Criteria Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours Increase or decrease in serum creatinine > 50% from reference in 7 days Urine output < 400 ml/day
Measure: AKI incidence Time: from hospital admission through hospital discharge upto 24 weeksDescription: initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay
Measure: Dialysis requirement Time: through study completion upto 1 year from enrollmentDescription: Deaths during primary hospitalization
Measure: hospital mortality Time: through study completion within 1 yearDescription: C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent Percentage of patinets with renal functioanl recovery based on serum creatinien levels classfied as C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent
Measure: Renal functional recovery Time: Assessed at at 3, 6 and 12 months from enrollment at hospital admissionDescription: EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment
Measure: Functional status Time: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admissionDescription: Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay
Measure: Resource utilization Time: Within 1 year of enrollment for primary hospitalizationThe purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.
Description: To evaluate the dose response effect of AZD5718 on urine ACR at 20 weeks
Measure: Change from baseline in urine ACR to Week 20 Time: Week 1 to Week 20Description: To evaluate the dose response effect of AZD5718 on urine ACR at 12 weeks
Measure: Change from baseline in urine ACR to Week 12 Time: Week 1 to Week 12Description: To assess the safety and tolerability profile of AZD5718 treatment
Measure: Number of participants with adverse events and serious adverse events Time: Screening to Week 24Description: To evaluate the effect of AZD5718 on ambulatory blood pressure
Measure: Change from baseline in 24-hours mean systolic blood pressure to Week 12 Time: Week 1 to Week 12Description: To assess the PK of AZD5718 after repeated oral dosing for 20 weeks
Measure: Plasma concentrations of AZD5718 Time: Week 2 to Week 20Description: To assess the effect of AZD5718 on renal function
Measure: Change from baseline in estimated glomerular filtration rate (eGFR) to Week 12 Time: Week 1 to Week 12The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK). The study is conducted in accordance with Food and Drug Administration guidance on Clinical Drug Interaction Studies, 2020. Verinurad will be developed as a fixed combination since it will always be administered together with allopurinol.
Description: Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with (cyclosporine or rifampicin), relative to reference treatment (verinurad+allopurinol alone) in each treatment period
Measure: Geometric mean ratio of maximum observed plasma peak concentration (Cmax) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Verinurad AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of area under plasma concentration-time curve from time zero to infinity (AUCinf) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Verinurad AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of area under the plasma concentration-time curve from zero to time of last quantifiable concentration (AUClast) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Cmax Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: AUCinf Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: AUClast Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUC(0-24) of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Area under the concentration-time curve from time zero to 24 hours post-dose [AUC(0-24)] Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: tmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Time to reach peak or maximum observed concentration following drug (tmax) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: t½λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Terminal elimination rate constant (λz) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: CL/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MRTinf of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Mean Residence Time of the unchanged drug in the systemic circulation (MRTinf) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Vss/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Volume of distribution (apparent) at steady state following extravascular administration (Vss/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Vz/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of Cmax for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Metabolite:Parent (MP) ratio of Cmax Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of AUCinf for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: MP ratio of AUCinf Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of AUClast for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: MP ratio of AUClast Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Observed values and change from baseline value in systolic and diastolic BP for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal blood pressure (BP) Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in pulse rate for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal pulse rate Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in temperature for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal temperature Time: For approximately 9 weeks (from screening to follow-up)Description: 12-lead resting ECG safety assessments if there are any abnormal findings for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal 12-lead electrocardiogram (ECG) Time: At screening and post-treatment follow-up visit (7-14 day after last dose of verinurad)Description: Any new or aggravated clinically relevant abnormal medical physical examination finding compared to the baseline assessment for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal physical examination Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in hematology parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal hematology parameters Time: At screening, Day -1, Day 3 (Treatment Periods 1, 2 and 3) and post-treatment follow-up (7-14 days after last dose of verinurad)Description: Observed values and change from baseline value in clinical chemistry parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal clinical chemistry parameters Time: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad)Description: Observed values and change from baseline value in urinalysis parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal urinalysis parameters Time: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad)Description: The number and percentage of subjects with AEs and the number of events for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with adverse events (AEs) and serious AEs Time: For approximately 9 weeks (from screening to follow-up)This study is a single centre, randomised, open-label, single-dose, 3-period, 3-treatment, crossover study in healthy male and female subjects. This study is intended to assess the relative bioavailability between the ph3 (fixed dose combination) and ph2b (free combination) formulations of verinurad and allopurinol. For verinurad, both formulations have an extended release profile. For allopurinol, both formulations have an immediate release profile.
Description: Area under plasma concentration time curve from time zero to infinity (AUCinf) of verinurad, allopurinol and oxypurinol.
Measure: Evaluation of the relative bioavailability of verinurad, allopurinol and oxypurinol after dosing with the ph3 and ph2b formulations under fasted conditions by AUCinf Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUClast) of verinurad, allopurinol and oxypurinol.
Measure: Evaluation of the relative bioavailability of verinurad, allopurinol and oxypurinol after dosing with the ph3 and ph2b formulations under fasted conditions by AUClast Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Maximum observed plasma (peak) drug concentration (Cmax) of verinurad, allopurinol and oxypurinol.
Measure: Evaluation of the relative bioavailability of verinurad, allopurinol and oxypurinol after dosing with the ph3 and ph2b formulations under fasted conditions by Cmax Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Area under plasma concentration time curve from time zero to infinity of verinurad, allopurinol and oxypurinol.
Measure: Evaluation of the relative bioavailability of verinurad, allopurinol and oxypurinol after dosing with the ph3 formulation under fed and fasted conditions by AUCinf Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration of verinurad, allopurinol and oxypurinol.
Measure: Evaluation of the relative bioavailability of verinurad, allopurinol and oxypurinol after dosing with the ph3 formulation under fed and fasted conditions by AUClast Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Maximum observed plasma (peak) drug concentration of verinurad, allopurinol and oxypurinol.
Measure: Evaluation of the relative bioavailability of verinurad, allopurinol and oxypurinol after dosing with the ph3 formulation under fed and fasted conditions by Cmax Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Area under plasma concentration time curve from time zero to infinity of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by AUCinf Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by AUClast Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Maximum observed plasma (peak) drug concentration of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by Cmax Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Time to reach maximum observed plasma concentration following drug administration (tmax) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by tmax Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Time delay between drug administration and the first observed concentration in plasma (tlag) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by tlag Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Terminal elimination rate constant (λz) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by λz Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by t½λz Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Apparent total body clearance of drug from plasms after extravascular administration (parent drug only) (CL/F) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by CL/F Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by MRTinf Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Volume of distribution (apparent) at steady state following extravascular administration (Vss/F) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by Vss/F Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of verinurad, allopurinol and oxypurinol.
Measure: Assessment of the pharmacokinetic profiles of verinurad, allopurinol and oxypurinol when administered as the ph3 formulation under fed and fasted conditions and the ph2b formulation in the fasted state by Vz/F Time: Days 1 to 4: pre-dose and upto 72 hours post-doseDescription: Assessment of the safety of single doses of verinurad and allopurinol.
Measure: Number of subjects with serious and non-serious adverse events Time: From Screening (Days -28 to -2) to follow-up visit (7 to 14 days post final dose)The study is designed as a multicenter, randomized , double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
Description: Evaluated at interim analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein to Creatinine Ratio sampled from a 24h urine collection.
Measure: Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months Time: Baseline and 9 monthsDescription: Evaluated at the final analysis - to demonstrate superiority of LNP023 vs. placebo in slowing renal disease progression measured by the annualized total slope of Estimated Glomerular Filtration Rate (eGFR) change over 24 months.
Measure: Annualized total Estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months). Time: Baseline and 24 monthsDescription: Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.
Measure: Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g at 9 months, without receiving Corticosteroids/Immunosuppressant or other newly approved drugs for treatment of IgAN or initiating Renal Replacement Therapy. Time: Baseline and 9 monthsDescription: Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing renal disease progression measured by the annualized total slope of Estimated Glomerular Filtration Rate change over 1 year.
Measure: Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months Time: Baseline and 12 monthsDescription: Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the change from baseline to 9 months in fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.
Measure: Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire Time: Baseline and 9 monthsDescription: Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on delaying the time to first occurrence of a composite renal endpoint of reaching either at least 30% change in Estimated Glomerular Filtration Rate, End-Stage Renal Disease or renal death.
Measure: Time from randomization to first occurrence of composite renal endpoint event, defined as reaching either ≥30% decline in Estimated Glomerular Filtration Rate (eGFR) relative to baseline, or End Stage Renal Disease (ESRD), or renal death Time: Up to 24 monthsDescription: Evaluated at final analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein To Creatinine Ratio sampled from a 24h urine collection.
Measure: Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months Time: Baseline and 9 monthsDescription: Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.
Measure: Proportion of participants reaching Urine Protein-To-Creatinine Ratio <1g/g at 9 months without receiving Corticosteroids/Immunosuppressant Therapy or other newly approved drugs for treatment of IgAN or initiating renal replacement therapy Time: Baseline and 9 monthsDescription: Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the change from baseline to 9 months in the fatigue scale measured by Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.
Measure: Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire. Time: Baseline and 9 monthsThe purpose of the study is to evaluate the efficacy and safety of AZD9977 alone and AZD9977 in combination with dapagliflozin and to assess the dose-response relationship of placebo, AZD9977 alone, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 55%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between 20 and 60 mL/min, with at least 30% of participants with eGFR <30 mL/min and a maximum of 25% of participants with eGFR >45 mL/min]), including at least 40% of participants with type 2 diabetes mellitus (T2DM).
Description: Evaluating the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on UACR.
Measure: Percent change from baseline in UACR at 12 weeks Time: Baseline (Day 1) until Week 12 (Day 85)Description: Assessment of the dose-response relationship of placebo, AZD9977 (Dose C) alone, dapagliflozin (10 mg) alone and 3 doses of AZD9977 (A, B or C) combined with dapagliflozin (10 mg) on UACR.
Measure: Percent change from baseline in UACR at 12 weeks to assess dose-response relationship Time: Baseline (Day 1) until Week 12 (Day 85)Description: Assessment of the general safety and tolerability of AZD9977 and dapagliflozin in combination and alone compared with placebo.
Measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From baseline (Day 1) until Day 113 (Safety Follow-up)Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on serum potassium.
Measure: Absolute value of serum potassium over time Time: Days 1, and 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on serum potassium.
Measure: Change from baseline in serum potassium over time Time: From baseline (Day 1), Day 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on eGFR.
Measure: Absolute value of eGFR over time Time: Days 1, and 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on eGFR.
Measure: Change from baseline in eGFR over time Time: From baseline (Day 1), Day 3 until Day 85This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN
Description: Safety and Tolerability
Measure: Incidence of Treatment-Emergent Adverse Events Time: Through study completion, an average of 18 monthsDescription: Safety and Tolerability
Measure: Incidence of Clinical Laboratory Assessments Time: Through study completion, an average of 18 monthsThis is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD. This study is planned to screen approximately 104 patients and randomize a minimum of 46 patients (maximum 60) with anemia of CKD from approximately 7 to 10 sites in China.
Description: Evaluation of main effect of roxadustat versus rHuEPO on GI iron absorption.
Measure: Difference from baseline to Day 15 in log-transformed area under curve (AUC) of GI iron absorption (0-3 hours) Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with baseline variables of roxadustat versus rHuEPO on iron absorption.
Measure: Difference from baseline to Day 15 in log-transformed AUC of iron absorption (0-3 hours) Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron.
Measure: Difference from baseline to Day 15 in serum iron Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: ferritin.
Measure: Difference from baseline to Day 15 in ferritin Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with key baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC.
Measure: Difference from baseline to Day 15 in total iron binding capacity (TIBC) Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with key baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT.
Measure: Difference from baseline to Day 15 in transferrin saturation (TSAT) Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with key baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: transferrin.
Measure: Difference from baseline to Day 15 in transferrin Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with key baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: soluble transferrin receptor.
Measure: Difference from baseline to Day 15 in soluble transferrin receptor Time: From baseline (Day 1) to Day 15Description: Assessment of effect and interaction with key baseline variables of roxadustat versus rHuEPO on hepcidin levels.
Measure: Difference from baseline to Day 15 in hepcidin levels Time: From baseline (Day 1) to Day 15Description: Assessment of safety by incidence of AEs, and measurement of vital signs (tympanic temperature, blood pressure (BP), pulse and respiratory rate), laboratory variables
Measure: Number of patients with adverse events (AEs) and serious adverse events (SAEs) Time: From Screening to 28-day Follow-up Period (Approximately 9 Weeks)Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. In older adults at risk of mobility impairment, exercise greatly reduced incidence and effects did not vary by frailty status. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known know that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional strength and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong will be delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition seminars and support groups over Microsoft® Teams. The primary aim of this study is to assess feasibility as determined by recruitment (25 people in 3 months), retention (80%), adherence (≥70%) and participant experience.
Description: The number of participants recruited at the end of rollout and participant experience.
Measure: Recruitment Time: Through study completion, an average of 12 weeksDescription: The number of participants retained at post-rollout end
Measure: Retention Time: Through study completion, an average of 12 weeksDescription: The percentage of exercise sessions completed
Measure: Adherence Time: Through study completion, an average of 12 weeksDescription: A semi-structured interview will ask about participant experience, satisfaction, learning needs, and suggested adaptations to the program. A semi-structured interview guide has been designed to conduct exit interviews and follow up interviews with each participant over the phone or web conference. Interviews will be audio-recorded and transcribed verbatim. One researcher will perform content analyses using NVivo version 12 Pro or higher (QSR International Pty Ltd, 2019) to describe participant experience, satisfaction, learning needs and suggested adaptations to the program. Analyses will be verified by another researcher through member checking. The exercise physiologist will be given a spreadsheet to record any protocol adaptations, challenges, and successes to inform future trials.
Measure: Participant experience Time: Week 12Description: A Physical Activity Screen (PAS) will be used to capture average minutes of moderate-to-vigorous physical activity each week. This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results will be compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week (Tremblay et al., 2011).
Measure: Physical activity Time: Baseline, week 9, week 12Description: A modified version of the Exercise Self-Efficacy Scale will be used to capture levels of planning and execution of exercise related activities (Resnick & Jenkins, 2000). The lowest response option to each question is "Not true at all", while the highest is "Exactly true". Responses closer to "Exactly true" indicate a better outcome.
Measure: Exercise self-efficacy scale Time: Baseline, week 9, week 12Description: The 30-second Chair Stand will be used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test have been adapted and will be self-administered under the remote supervisor supervision of the exercise physiologist. A higher score on this test indicates a better outcome.
Measure: 30-second Chair Stand Time: Baseline, week 9, week 12Description: Static balance will be measured using the 3-point scale from the Short Performance Physical Battery (J. M. Guralnik et al., 1994). The instructions for this test have been adapted and will be self-administered under the remote supervisor supervision of the exercise physiologist. A higher score on this test indicates a better outcome.
Measure: Static balance Time: Baseline, week 9, week 12Description: Fatigue will be assessed with the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) Depression Scale (Radloff, 1977). Only two questions on the CES-D will be used: "I felt that everything I did was an effort, "I could not get going". The lowest response option is "Rarely (<1 day)", and the highest response option is "Nearly every day". Responses closer to the lowest response option indicate a better outcome.
Measure: Fatigue Time: Baseline, week 9, week 12Description: Warwick-Edinburgh Mental Well-being Scale focuses on positive aspects of mental health. It is short, yet robust and showed high correlations with other mental health and well-being scales. The lowest response option is "None of the time", and the highest response option is "All of the time". Responses closer to the highest response option indicate a better outcome.
Measure: Mental health and social isolation Time: Baseline, week 9, week 12Description: The EuroQol Group 5 Dimension 5 Level questionnaire is a multi-attribute health related quality of life tool (Herdman et al., 2011). The system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems to extreme problems five dimensions can be combined into a 5-digit number that describes the self rated patient's health state. Responses to each dimension are scored as a number from 1-5. Responses scored as 1 indicate a better outcome.
Measure: Quality of life score Time: Baseline, week 9, week 12Description: The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool will be used to assess changes in weight, appetite, eating habits and promote viable self-management.
Measure: Dietary intake Time: Baseline, week 9, week 12Description: ASA24®-Canada is a guided web-based tool used for 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) will be reported to track protein intake (Subar et al., 2012).
Measure: Nutrition tracking Time: Baseline, week 9, week 12Description: We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Measure: Number of adverse events Time: Through study completion, an average of 12 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports