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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Finerenone 10mg or 20mg tablets, oral, once daily
Finerenone matched placebo tablets, oral, once daily
eGFR slope
eGFR slope calculated using eGFR values from randomisation to week 108
Time frame: 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
Time frame: 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
Time frame: From randomisation to week 108
All-cause mortality at 108 weeks
Incidence of death from any cause
Time frame: 108 weeks
Number of cardiovascular events
Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
1,000
The Canberra Hospital
Garran, Australian Capital Territory, Australia
RECRUITINGNepean Blue Mountains Local Health District
Kingswood, New South Wales, Australia
RECRUITINGSt George Hospital
Kogarah, New South Wales, Australia
RECRUITINGJohn Hunter Hospital
New Lambton Heights, New South Wales, Australia
RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
RECRUITINGSunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
RECRUITINGTownsville University Hospital
Douglas, Queensland, Australia
RECRUITINGWest Moreton Hospital & Health Service
Ipswich, Queensland, Australia
RECRUITINGGold Coast Hospital and Health Service
Southport, Queensland, Australia
RECRUITINGRoyal Adelaide
Adelaide, South Australia, Australia
RECRUITING...and 22 more locations
Time frame: From randomisation to week 108