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.
CAPTIVATE includes multiple domains examining different therapies for CKD. Participants may enrol in one or more domains and domains will be added and closed over time. The platform operates under a core protocol with each domain described in a domain specific appendix.
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
Urine albumin-creatinine ratio (uACR) >200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) >300 mg/g (33.9 mg/mmol) at time of screening.
On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i*, for 4 weeks before screening according to treating physician.
Factorial
Finerenone
DrugFinerenone 10mg or 20mg tablets, oral, once daily
Placebo Finerenone
DrugFinerenone matched placebo tablets, oral, once daily
Semaglutide
DrugSemaglutide 1.0mg or 2.4mg pen injector, subcutaneous injection, once weekly
Placebo semaglutide
DrugSemaglutide matched pen injector, subcutaneous injection, once weekly
Core Primary Outcome Measure
The primary outcome is chronic eGFR slope. Chronic eGFR slope measures the rate of eGFR decline while on treatment. The duration of time over which chronic eGFR slope is computed can vary by domain and is determined by clinical considerations such as whether the investigational product can cause an acute decline in eGFR upon initiation. DSAs will specify the duration of time over which chronic eGFR slope is computed for the individual domain.
MRA Domain Primary Outcome Measure
Chronic eGFR slope estimated from all available eGFR values from week 4 to the end of treatment. The final eGFR value that contributes to the primary outcome is the last eGFR measured while the participant is on treatment.
GLP1-RA Domain Primary Outcome Measure
Chronic eGFR slope estimated from all available eGFR values from Week 0 to the end of treatment. The final eGFR value that contributes to the primary outcome is the last eGFR measured while the participant is on treatment.
Core Protocol Secondary outcomes
1\. Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between week 0 and 24 weeks, measured as a continuous variable.
Core Protocol Secondary outcomes
2\. eGFR slope from week 0 to end of washout
Core Protocol Secondary outcomes
3\. Change in eGFR from week 0 to end of washout
Core Protocol Secondary outcomes
4\. Composite outcome of proportion of participants experiencing a ≥40% eGFR decline between week 0 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.
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