NCT06058585

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Finerenone	Finerenone 10mg or 20mg tablets, oral, once daily
DRUG	Placebo Finerenone	Finerenone matched placebo tablets, oral, once daily

Timeline

• Start date: 2024-09-04
• Primary completion: 2028-08-30
• Completion: 2029-03-31
• First posted: 2023-09-28
• Last updated: 2026-04-01

Locations

43 sites across 5 countries: Australia, India, New Zealand, Spain, Sri Lanka