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Report for D051436: Renal Insufficiency, Chronic NIH
(Synonyms: Renal Insufficiency, C, Renal Insufficiency, Ch, Renal Insufficiency, Chro, Renal Insufficiency, Chron, Renal Insufficiency, Chronic)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug119 | AZD5718 Wiki | 0.45 |
| drug180 | Allopurinol Wiki | 0.45 |
| drug3056 | Verinurad Wiki | 0.45 |
| drug867 | Detection of anti-COVID-19 antibody level Wiki | 0.45 |
| drug1041 | Exercise training group Wiki | 0.45 |
| drug879 | Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta Wiki | 0.45 |
| drug834 | Dapagliflozin 10 mg Wiki | 0.45 |
| drug749 | Control-EDI Wiki | 0.45 |
| drug1460 | Intervention-EDI and health coaching Wiki | 0.45 |
| drug2122 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007674 | Kidney Diseases NIH | 0.79 |
| D002908 | Chronic Disease NIH | 0.26 |
| D051437 | Renal Insufficiency, NIH | 0.20 |
| D007154 | Immune System Diseases NIH | 0.18 |
| D006973 | Hypertension NIH | 0.12 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012622 | Chronic kidney disease HPO | 1.00 |
| HP:0000077 | Abnormality of the kidney HPO | 0.79 |
| HP:0000083 | Renal insufficiency HPO | 0.20 |
| HP:0000822 | Hypertension HPO | 0.12 |
There are 5 clinical trials
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 Chronic Kidney Diseases Chronic Disease Chronic Kidney Disease, Stage 3 (Moderate) Chronic Kidney Disease, Stage 4 (Severe) Chronic Kidney Disease Stage 5 Behavioral: Control-EDI 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 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
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 monthsSecondary 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 monthsDescription: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Measure: Slope of systolic BP between baseline and 12 months using all available BP values Time: Baseline up to 12 monthsDescription: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Measure: Slope of diastolic BP between baseline and 12 months using all available BP values Time: Baseline up to 12 monthsDescription: This is a 28-item questionnaire measuring objective CKD disease knowledge and includes questions about goals, cardiovascular risk, and anti-hypertensive medications. Patients will answer the questions with a yes or no answer and their score will be based on how many responses were correct. This number will be converted to a percentage.
Measure: CKD knowledge measured by the Kidney Knowledge Survey (KiKS) Time: Baseline up to 12 monthsDescription: This is a 13-item measure with the answers on a Likert scale of 1 (not at all sure) to 4 (extremely sure). The higher the score the higher the self-efficacy, with a range from 13-52.
Measure: Medication Adherence Self-Efficacy Scale-Revised (MASES-R) Time: Baseline up to 12 monthsDescription: This scale is to quantify adherence to pharmacological treatments by means of 8 items. Patients will answer yes or no to these items, where a no response = 1 point and a yes response = 0 points. Levels of adherence are based on the following scores: 3-8 = low adherence; 1-2 = medium adherence; 0 = high adherence.
Measure: Morisky Medication Adherence Scale (MMAS - 8) Time: Baseline up to 12 monthsDescription: Length of time provider spends with the patient. This will be compared between the intervention group and control group.
Measure: Visit Time with provider Time: Enrollment visit (baseline)Description: Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.
Measure: Total time in clinic Time: Enrollment visit (baseline)Description: This contains a 17-item questionnaire in which the participants select scores from 1-7 or does not apply. A number of 1 = not at all and a score of 7 = considered very true, and zero = not applicable.
Measure: Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ) Time: Baseline up to 12 monthsDescription: This is a 15-item questionnaire that assesses the quality of physician to patient communication completed by the patients. There are 5 answers to choose from; poor, fair, good, very good, and excellent. The Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.
Measure: Satisfaction with CKD care based on Communication Assessment Tool (CAT) Time: Baseline up to 12 monthsDescription: This is a 21-item questionnaire that is completed by the patients, and select from the the 4 choices: very strongly agree, strongly agree, agree, and neutral/disagree. Each answer is worth one point on a Likert scale with a higher score meaning more satisfied.
Measure: Satisfaction with CKD care based on Consultation Care Measure (CCM) Time: Baseline up to 12 monthsDescription: During health coach phone calls, participants will be asked 37 questions about their perceptions of the health coach program, including how much their participation in CHECK-D helped participants change various behaviors. Participant responses will be used to examine various measures of reliability and validity during the analyses of data acquired though this survey.
Measure: Perceptions of health coaching for the intervention group Time: Baseline up to 12 monthsDescription: The EMR will be reviewed to evaluate the patients medication refills for adherence.
Measure: Medication adherence from the electronic medical record (EMR) Time: Baseline up to 12 monthsDescription: This is an 8-item scale regarding self-efficacy where each statement is rated on the level of agreement from 1-5. 1 is disagree and 5 is agree.
Measure: Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS) Time: Baseline up to 12 monthsDescription: This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.
Measure: Self-reported Blood Pressure-Related Behaviors Survey Time: Baseline up to 12 monthsDescription: Provider adoption will be measured by the percentage of enrolled patients whose providers used the EDI with them during their visit. Data will be collected by EMR query and a 1-item question in the patient survey.
Measure: Provider Adoption based on EMR query and patient survey Time: BaselineDescription: Provider fidelity will be measured by the percentage of enrolled patients in the intervention clinics whose providers entered 1-2 patient specific goals in the EDI. This will be collected through EMR query.
Measure: Provider Fidelity measured by EMR query Time: BaselineDescription: Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.
Measure: Provider Perception of Usefulness by provider survey Time: Baseline up to 12 monthsDescription: Change in Serum Creatinine between baseline and 12-months
Measure: Change in serum creatinine Time: Baseline, 12 monthsMeasure: Change in urine protein-creatinine ratio Time: Baseline, 12 months
Measure: Change in estimated glomerular filtration rate (eGFR) Time: Baseline, 12 months
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 Healthy Volunteers (Intended Indication: Chronic Kidney Disease) Drug: Verinurad Drug: Placebo 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
3 Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
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-doseDescription: To assess the effect of a single dose of verinurad given as either a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supra-therapeutic exposure), both in combination with allopurinol 300 mg, on the QTcF interval compared to placebo using a concentration-QTcF interval analysis
Measure: Baseline-corrected and placebo-adjusted QTcF interval (ΔΔQTcF) Time: Screening; Visit 2,3,4:- Day -1, 1,2, 3; Follow up visit (7 to 10 days after the last dose)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 doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted heart rate (ΔΔHR) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected RR interval (ΔRR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted RR interval (ΔΔRR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected PR interval (ΔPR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted PR interval (ΔΔPR interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QRS interval (ΔQRS interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QRS interval (ΔΔQRS interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected QT interval (ΔQT interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QT interval (ΔΔQT interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected QTcF interval (ΔQTcF interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg
Measure: Baseline-corrected and placebo-adjusted QTcF interval (ΔΔQTcF interval) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To assess the pharmacokinetics (PK) of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Area under plasma concentration-time curve from zero to infinity (AUC) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects.
Measure: Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC0-t) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Maximum observed plasma concentration (Cmax) Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Time to reach maximum observed plasma concentration (tmax) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Time delay between drug administration and the first observed concentration in plasma (tlag) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Time of last quantifiable plasma concentration (tlast) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Apparent total body clearance of drug from plasma after extravascular administration (parent drug only) [CL/F] Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Apparent volume of distribution during the terminal phase after extravascular administration (parent drug only) [Vz/F] Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Apparent volume of distribution at steady state (Vss/F) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects
Measure: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT) Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-doseDescription: To assess clinical chemistry/hematology/urinalysis as a variable of safety and tolerability of verinurad and allopurinol
Measure: Number of subjects with abnormal haematology, clinical chemistry and urinalysis Time: Screening; Visit 2,3 and 4:- Day -1, Day 3: 48 h post-dose, Follow up periodDescription: To assess vital signs as a variable of safety and tolerability of verinurad and allopurinol
Measure: Number of subjects with abnormal blood pressure and pulse rate Time: Screening; Visit 2,3 and 4:- Day -1, Day 1: pre-dose, 1 and 6 h post-dose; Day 2: 24 h post-dose; Day 3: 48 h post-dose, Follow up visitData 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 Chronic Disease Chronic Diseases in Adolescence Chronic Disease of Immune System Chronic Kidney Diseases Other: Exercise training group MeSH:Kidney Diseases Renal Insufficiency, Chronic Chronic Disease Immune System Diseases
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
4 Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection
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-upSecondary Outcomes
Description: Semi structured interview
Measure: Patients perceptions during social isolation Time: From baseline to 3 months of follow-upDescription: Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
Measure: Adolescents quality of life Time: From baseline to 3 months of follow-upDescription: Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
Measure: Disease activity Time: From baseline to 3 months of follow-upDescription: Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
Measure: Disease overall assessment Time: From baseline to 3 months of follow-upDescription: Will be assessed by means of Strengths & Difficulties Questionnaires
Measure: Strengths and difficulties Time: From baseline to 3 months of follow-upThe coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions. In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.
NCT04491227 Covid19 AKI CKD ESRD 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
5 A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
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 weeksDescription: initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay
Measure: Dialysis requirement Time: through study completion upto 1 year from enrollmentDescription: Deaths during primary hospitalization
Measure: hospital mortality Time: through study completion within 1 yearSecondary 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 admissionDescription: EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment
Measure: Functional status Time: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admissionDescription: Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay
Measure: Resource utilization Time: Within 1 year of enrollment for primary hospitalizationThe purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.
NCT04492722 Chronic Kidney Disease Drug: AZD5718 Drug: Dapagliflozin 10 mg 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 albumin to creatinine ratio (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
HPO Nodes
HP:0012622: Chronic kidney disease
Genes 127
PAX2 NPHP4 JAG1 SEC61A1 WT1 TMEM231 SDCCAG8 IQCB1 BICC1 COL4A4 TMEM67 WT1 TSC2 FAN1 NPHP1 IFT172 TBC1D8B SGPL1 MAGI2 GANAB NPHP4 NPHP3 CLCN5 CEP83 OCRL MUC1 NEK8 KYNU GLIS2 NUP160 TRPC6 TTC21B COL4A3 PYGM DCDC2 GATA3 TMEM67 SH2B1 CFH INF2 SAA1 AHI1 PKD2 CEP164 CFHR5 DNAJB11 CTNS INVS ALDOB CLCN5 IFT140 CD151 LAGE3 AGXT TMEM126B PKD1 NUP85 RAD51C TP53RK CEP290 MMUT SLC7A7 FN1 CEP290 ANLN DSTYK GSN XPNPEP3 MYO1E COQ8B IFT43 COL4A3 NUP205 CLDN16 IQCB1 WDR19 WDR19 NUP107 TSC1 FLT1 NUP93 DZIP1L NUP107 LAMB2 CORIN TMEM67 NOD2 SPRY2 INVS ARHGDIA NPHS2 TRAF3IP1 WDR19 TTC21B STOX1 LAMB2 PLCE1 DGKE MAPKBP1 CEP290 APOL1 NPHP4 CTNS CLDN19 UMOD PUS3 PAX2 NUP133 SARS2 TRAF3IP1 NPHP3 WDR19 PKD2 APRT LZTFL1 BNC2 HNF1B COL4A5 ACTN4 IFT122 NPHP1 CLCN5 TPRKB NPHP1 REN OSGEP SOX18 Protein Mutations 1
C677T
Primary Outcomes
Description: To evaluate the dose-response effect of AZD5718 on urine ACR at 20 weeks
Measure: Change from baseline in urine albumin to creatinine ratio (ACR) to Week 20 Time: Week 1 to Week 20Secondary 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 12Description: To assess the safety and tolerability profile of AZD5718 treatment
Measure: Number of participants with adverse events and serious adverse events Time: Screening to Week 24Description: To evaluate the effect of AZD5718 on ambulatory blood pressure
Measure: Change from baseline in 24-hours mean systolic blood pressure to Week 12 Time: Week 1 to Week 12Description: To assess the PK of AZD5718 after repeated oral dosing for 20 weeks
Measure: Plasma concentrations of AZD5718 Time: Week 2 to Week 20Description: To assess the effect of AZD5718 on renal function
Measure: Change from baseline in estimated glomerular filtration rate (eGFR) to Week 12 Time: Week 1 to Week 12