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  • HP:0012622: Chronic kidney disease
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    HP:0012622: Chronic kidney disease

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (18)


    Name (Synonyms) Correlation
    drug4647 Verinurad Wiki 0.55
    drug277 Allopurinol Wiki 0.55
    drug5175 rHuEPO Wiki 0.32
    Name (Synonyms) Correlation
    drug2186 Intervention-EDI and health coaching Wiki 0.32
    drug3734 Roxadustat Wiki 0.32
    drug1250 Dapagliflozin 10 mg Wiki 0.32
    drug1261 Data collection and clinical testing of subjects Wiki 0.32
    drug1131 Control-EDI Wiki 0.32
    drug1572 Exercise training group Wiki 0.32
    drug3693 Rifampicin Wiki 0.22
    drug189 AZD9977 Wiki 0.22
    drug178 AZD5718 Wiki 0.22
    drug1238 DWRX2003 Wiki 0.18
    drug502 BI 764198 Wiki 0.18
    drug1248 Dapagliflozin Wiki 0.16
    drug531 BNT162b2 Wiki 0.16
    drug1213 Cyclosporine Wiki 0.14
    drug3195 Placebo Wiki 0.06

    Correlated MeSH Terms (8)


    Name (Synonyms) Correlation
    D051436 Renal Insufficiency, Chronic NIH 1.00
    D007674 Kidney Diseases NIH 0.77
    D000740 Anemia NIH 0.32
    Name (Synonyms) Correlation
    D002908 Chronic Disease NIH 0.16
    D007154 Immune System Diseases NIH 0.13
    D051437 Renal Insufficiency, NIH 0.11
    D006333 Heart Failure NIH 0.08
    D006973 Hypertension NIH 0.06

    Correlated HPO Terms (5)


    Name (Synonyms) Correlation
    HP:0000077 Abnormality of the kidney HPO 0.77
    HP:0001903 Anemia HPO 0.32
    HP:0000083 Renal insufficiency HPO 0.11
    Name (Synonyms) Correlation
    HP:0001635 Congestive heart failure HPO 0.08
    HP:0000822 Hypertension HPO 0.06

    Clinical Trials

    Navigate: Correlations   HPO

    There are 10 clinical trials


    1 Controlling Hypertension Through Education and Coaching in Kidney Disease

    Chronic 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.

    NCT04087798
    Conditions
    1. Chronic Kidney Diseases
    2. Chronic Disease
    3. Chronic Kidney Disease, Stage 3 (Moderate)
    4. Chronic Kidney Disease, Stage 4 (Severe)
    5. Chronic Kidney Disease Stage 5
    Interventions
    1. Behavioral: Control-EDI
    2. Behavioral: Intervention-EDI and health coaching
    MeSH:Kidney Diseases Renal Insufficiency, Chronic Hypertension Chronic Disease
    HPO:Abnormality of the kidney Chronic kidney disease Hypertension Nephropathy

    Primary Outcomes

    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 months

    Secondary Outcomes

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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: Baseline

    Description: 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: Baseline

    Description: 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 months

    Description: Change in Serum Creatinine between baseline and 12-months

    Measure: Change in serum creatinine

    Time: Baseline, 12 months

    Measure: Change in urine protein-creatinine ratio

    Time: Baseline, 12 months

    Measure: Change in estimated glomerular filtration rate (eGFR)

    Time: Baseline, 12 months
    2 Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BI 764198 in Subjects With Moderate and Severe Renal Impairment in Comparison to Subjects With Normal Renal Function (a Mono-centric, Open-label Study With Matched-pair Design)

    The 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.

    NCT04176536
    Conditions
    1. Healthy
    2. Chronic Kidney Disease
    Interventions
    1. Drug: BI 764198
    MeSH:Kidney Diseases Renal Insufficiency, Chronic
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    Measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time: Up to 96 hours

    Measure: Cmax (maximum measured concentration of the analyte in plasma)

    Time: Up to 96 hours

    Secondary Outcomes

    Measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 the last quantifiable data point)

    Time: Up to 96 hours
    3 Single-Centre, Randomised, Double-Blind, 3-Period Cross-Over Study to Investigate Effects on QTcF Interval of Verinurad ER 24 mg or IR 40 mg in Combination With Allopurinol 300 mg, Compared to Matching Placebos In Healthy Volunteers

    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

    NCT04256629
    Conditions
    1. Healthy Volunteers (Intended Indication: Chronic Kidney Disease)
    Interventions
    1. Drug: Verinurad
    2. Drug: Placebo
    3. Drug: Allopurinol
    MeSH:Kidney Diseases Renal Insufficiency, Chronic
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    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-dose

    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: 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)

    Secondary Outcomes

    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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 dose

    Description: 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-dose

    Description: 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 dose

    Description: 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 dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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 period

    Description: 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 visit
    4 Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial

    Data 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.

    NCT04458246
    Conditions
    1. Chronic Disease
    2. Chronic Diseases in Adolescence
    3. Chronic Disease of Immune System
    4. Chronic Kidney Diseases
    Interventions
    1. Other: Exercise training group
    MeSH:Kidney Diseases Renal Insufficiency, Chronic Immune System Diseases Chronic Disease
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    Description: Semi structured interview

    Measure: Safety and efficacy of a home-based exercise training program

    Time: From baseline to 3 months of follow-up

    Secondary Outcomes

    Description: Semi structured interview

    Measure: Patients perceptions during social isolation

    Time: From baseline to 3 months of follow-up

    Description: 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-up

    Description: 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-up

    Description: 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-up

    Description: Will be assessed by means of Strengths & Difficulties Questionnaires

    Measure: Strengths and difficulties

    Time: From baseline to 3 months of follow-up
    5 Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

    The 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.

    NCT04491227
    Conditions
    1. Covid19
    2. AKI
    3. CKD
    4. ESRD
    5. Transplant;Failure,Kidney
    MeSH:Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy Renal insufficiency

    Primary Outcomes

    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 weeks

    Description: initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay

    Measure: Dialysis requirement

    Time: through study completion upto 1 year from enrollment

    Description: Deaths during primary hospitalization

    Measure: hospital mortality

    Time: through study completion within 1 year

    Secondary Outcomes

    Description: 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 admission

    Description: 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 admission

    Description: 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 hospitalization
    6 A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

    The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.

    NCT04492722
    Conditions
    1. Chronic Kidney Disease
    Interventions
    1. Drug: AZD5718
    2. Drug: Dapagliflozin 10 mg
    3. Drug: Placebo
    MeSH:Kidney Diseases Renal Insufficiency, Chronic
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    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 20

    Secondary Outcomes

    Description: 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 12

    Description: 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 24

    Description: 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 12

    Description: To assess the PK of AZD5718 after repeated oral dosing for 20 weeks

    Measure: Plasma concentrations of AZD5718

    Time: Week 2 to Week 20

    Description: 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 12
    7 An Open-label, 3-Treatment, 3-Period, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Verinurad and Allopurinol When Administered Alone, and in Combination With Single Doses of Cyclosporine or Rifampicin

    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.

    NCT04532918
    Conditions
    1. Chronic Kidney Disease
    Interventions
    1. Drug: Verinurad
    2. Drug: Allopurinol
    3. Drug: Cyclosporine
    4. Drug: Rifampicin
    MeSH:Kidney Diseases Renal Insufficiency, Chronic
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    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-dose

    Description: 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-dose

    Description: 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-dose

    Secondary Outcomes

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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)
    8 A Randomised, Single-dose, 3-period, 3-treatment, Crossover Study to Assess the Relative Bioavailability of 2 Different Formulations of Verinurad and Allopurinol in Healthy Subjects

    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.

    NCT04550234
    Conditions
    1. Chronic Kidney Disease
    Interventions
    1. Drug: Verinurad
    2. Drug: Allopurinol
    MeSH:Kidney Diseases Renal Insufficiency, Chronic
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    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-dose

    Description: 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-dose

    Description: 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-dose

    Secondary Outcomes

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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-dose

    Description: 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)
    9 A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure With Left Ventricular Ejection Fraction (LVEF) Below 55% and Chronic Kidney Disease

    The 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).

    NCT04595370
    Conditions
    1. Heart Failure
    2. Chronic Kidney Disease
    Interventions
    1. Drug: AZD9977
    2. Drug: Dapagliflozin
    3. Drug: Placebo
    MeSH:Kidney Diseases Renal Insufficiency, Chronic Heart Failure
    HPO:Abnormal left ventricular function Abnormality of the kidney Chronic kidney disease Congestive heart failure Nephropathy Right ventricular failure

    Primary Outcomes

    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)

    Secondary Outcomes

    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 85

    Description: 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 85

    Description: 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 85

    Description: 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 85
    10 ALTAI: An Open-Label, Randomized, Active-Controlled, Parallel Design, Multicenter Phase IV Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)

    This 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.

    NCT04655027
    Conditions
    1. Anemia of Chronic Kidney Disease
    Interventions
    1. Drug: Roxadustat
    2. Drug: rHuEPO
    MeSH:Kidney Diseases Renal Insufficiency, Chronic Anemia
    HPO:Abnormality of the kidney Anemia Chronic kidney disease Nephropathy

    Primary Outcomes

    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 15

    Secondary Outcomes

    Description: 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 15

    Description: 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 15

    Description: 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 15

    Description: 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 15

    Description: 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 15

    Description: 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 15

    Description: 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 15

    Description: 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 15

    Description: 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)

    HPO Nodes


    Reports

    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.

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