Chronic Kidney Diseases
Conditions
Keywords
Chronic kidney disease, Mineralocorticoid Receptor Antagonist, Finerenone
Brief summary
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
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.
Interventions
DRUGFinerenone
Finerenone 10mg or 20mg tablets, oral, once daily
DRUGPlacebo Finerenone
Finerenone matched placebo tablets, oral, once daily
Sponsors
The George Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The default position within CAPTIVATE is that treatment allocations determined by randomisation will be provided on a blinded basis. Blinding, however, may not always be feasible particularly for behavioural or device-related interventions.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2) 3. Currently receiving standard of care treatment according to treating physician 4. Eligible for randomisation in at least one recruiting domain-specific appendix 5. Participant and treating physician are willing and able to perform trial procedures
Exclusion criteria
1. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 2. Life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR slope | From randomisation to week 108 | eGFR slope calculated using eGFR values from randomisation to week 108 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in albuminuria | From randomisation to week 24 | 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 | From randomisation to week 108 | 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 | 108 weeks | Incidence of death from any cause |
| Number of cardiovascular events | 108 weeks | Number of cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) |
| Safety and tolerability of treatment | 108 weeks | Incidence and rates of adverse events, and time from commencement of study treatment until interruption of treatment due to toxicity. |
| Change in quality of life | From randomisation to week 108 | 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 |
Countries
Australia, India, New Zealand, Spain, Sri Lanka
Contacts
CONTACTEnmoore Lin
STUDY_CHAIRSradha Kotwal
The George Institute
STUDY_CHAIRHiddo Lambers Heerspink
The George Institute
Outcome results
None listed