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D051436: Renal Insufficiency, Chronic

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 (7)


Name (Synonyms) Correlation
D007674 Kidney Diseases NIH 0.77
D000740 Anemia NIH 0.32
D002908 Chronic Disease NIH 0.16
Name (Synonyms) Correlation
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 (6)


Name (Synonyms) Correlation
HP:0012622 Chronic kidney disease HPO 1.00
HP:0000077 Abnormality of the kidney HPO 0.77
HP:0001903 Anemia HPO 0.32
Name (Synonyms) Correlation
HP:0000083 Renal insufficiency HPO 0.11
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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