The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Study Overview
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Brief Summary
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CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD). CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure. CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.

Detailed Description
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Chronic kidney disease (CKD) affects over 800 million people globally and is projected to be the 5th most common cause of death by 2040. CKD progresses to kidney failure, increases the risk of early death, heart disease, and leads to a poorer quality of life. Current treatments do not entirely remove the risk of kidney failure in people with CKD. To improve the outcomes of people with CKD, it is crucial to find the best treatment or combination of treatments that can slow CKD progression. CAPTIVATE aims to address this need. CAPTIVATE has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working. Participants can participate in more than one treatment at the same time or at different times. Participants receive each study treatment for 2 years. For each treatment, participants are followed up at study visits that occur at approximately one month, 3 months, 6 months, 12 months, 18 months and 2 years after starting treatment. A final study visit occurs one month after the end of the 2-year treatment phase. Information collected at study visits include blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.

Official Title
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The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Mineralocorticoid receptor antagonist
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2) Currently receiving standard of care treatment according to treating physician Eligible for randomisation in at least one recruiting domain-specific appendix Participant and treating physician are willing and able to perform trial procedures Exclusion Criteria: Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months Life expectancy less than 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Adaptive platform trial evaluating multiple interventions in multiple domains of therapeutic care. Additional interventions and participants will be added as the trial grows.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineralocorticoid receptor antagonist<br>Mineralocorticoid receptor antagonist | Drug: Mineralocorticoid receptor antagonist<br>* Oral, once daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Matched placebo tablets, oral, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR slope | eGFR slope calculated using eGFR values from randomisation to week 108 | From randomisation to week 108 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in albuminuria | Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable | From randomisation to week 24 | 
| Composite of 40% eGFR decline or kidney failure | Composite outcome of proportion of participants experiencing a 40% eGFR decline between randomisation and 108 weeks, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m2 or chronic kidney replacement therapy start) at 108 weeks | From randomisation to week 108 | 
| All-cause mortality at 108 weeks | Incidence of death from any cause | 108 weeks | 
| Number of cardiovascular events | Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) | 108 weeks | 
| Safety and tolerability of treatment | Incidence and rates of adverse events, and time from commencement of study treatment until interruption of treatment due to toxicity. | 108 weeks | 
| Change in quality of life | Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) at 6-monthly intervals from randomisation to week 108 | From randomisation to week 108 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Mineralocorticoid Receptor Antagonist