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.
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
Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
Life expectancy less than 6 months
Factorial
Finerenone
DrugFinerenone 10mg or 20mg tablets, oral, once daily
Placebo Finerenone
DrugFinerenone matched placebo tablets, oral, once daily
eGFR slope
eGFR slope calculated using eGFR values from randomisation to week 108
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
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
All-cause mortality at 108 weeks
Incidence of death from any cause
Number of cardiovascular events
Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)
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