CAPTIVATE Trial

Study Overview

The CAPTIVATE is a Phase 3, randomized, double-blind, placebo-controlled platform adaptive trial evaluating investigational therapies for adults with CKD. Participants are randomized to receive either finerenone or placebo, alongside standard-of-care therapy. The trial includes long-term follow-up over 108 weeks to assess kidney function, safety, and treatment effectiveness.

What Is a Platform Adaptive Trial?

A platform adaptive trial is a flexible clinical trial design that allows multiple therapies to be tested simultaneously. It adapts over time based on interim results, ineffective treatments can be dropped, promising therapies can be expanded, and new interventions can be added, enabling faster and more efficient evaluation of treatments.

Sri Lanka’s Contribution to the Trial

Sri Lankan is enrolling patients from:

• National Hospital of Sri Lanka
• National Nephrology Specialized Hospital
• Colombo North Teaching Hospital
• National Hospital Kandy
• Teaching Hospital Kurunegala
• Teaching Hospital Peradeniya
• Sri Jayewardenepura General Hospital

Study Methodology

• Randomized allocation to investigational agent or placebo
• Double-blind design for participants, investigators, and outcome assessors
• Standardized measurement of kidney function via eGFR and albuminuria
• Monitoring of adverse events and serious safety outcomes
• Long-term follow-up to evaluate sustained efficacy and safet

Key Results (anticipated)

• Slower decline in kidney function (eGFR slope)
• Reduction in albuminuria, a marker of kidney damage
• Lower incidence of composite outcomes, such as ≥40% eGFR decline or kidney failure
• Favourable safety and tolerability
• Insights into multiple investigational agents or combinations

By leveraging an adaptive platform design, CAPTIVATE efficiently evaluates multiple therapies, accelerates learning, and contributes to improving CKD management globally.

Read More: https://www.captivatetrial.org/about-captivate/