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

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

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.

It had four arms (groups): Finerenone (experimental), Placebo Finerenone (placebo comparator), Semaglutide (experimental) and Placebo Semaglutide (placebo comparator).

Finerenone matched placebo tablets.

The registry classes the interventions as drug.

More on the Plan

Current treatments do not entirely remove the risk of kidney failure in people with CKD.

CAPTIVATE aims to address this need.

CAPTIVATE has been designed to test multiple treatments within a common research platform.

The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up.

Who Took Part

The registry lists 2000 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Currently receiving standard of care treatment according to treating physician. Eligible for randomisation in at least one recruiting domain-specific appendix. Participant and treating physician are willing and able to perform trial procedures.

The full record lists 5 inclusion and 34 exclusion criteria; among the exclusions: planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months; life expectancy less than 6 months; treating physician believes finerenone is clinically appropriate for the participant.

How the Study Was Run

Design: randomized, factorial and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-09-04 with completion listed for 2029-12-31.

It ran at 51 sites in India (19), Australia (13), Sri Lanka (9), New Zealand (7) and Spain (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Core Primary Outcome Measure (time frame: From randomisation to week 108). MRA Domain Primary Outcome Measure (time frame: From week 4 to week 108). GLP1-RA Domain Primary Outcome Measure (time frame: From week 0 to week 108).

It also tracked 22 secondary outcomes, for example Core Protocol Secondary outcomes, Core Protocol Secondary outcomes, Core Protocol Secondary outcomes, Core Protocol Secondary outcomes, Core Protocol Secondary outcomes and Core Protocol Secondary outcomes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 2000 people.

With 2000 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.