Chronic Kidney Disease Adaptive Platform Trial Testing Multiple Treatments to Slow Disease Progression

What this Trial Is About

Chronic kidney disease CKD affects over 800 million people worldwide and is expected to become the fifth leading cause of death by 2040. This trial investigates various treatments to find the best options or combinations that slow CKD progression and reduce the risk of kidney failure and related complications. The study is a Phase III, international, multi-center, adaptive, platform trial designed to answer multiple treatment questions efficiently within a common setup. Participants receive study treatments, such as finerenone tablets 10mg or 20mg or matched placebo tablets, taken orally once daily. Each treatment period lasts 2 years, with follow-up visits scheduled at about 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment. A final visit occurs one month after completing the 2-year treatment phase. The trial is ongoing and allows participants to join multiple treatment arms either simultaneously or at different times. During the study visits, researchers collect blood and urine tests, evaluate safety, and monitor treatment adherence. Overall health status is assessed every 5 years. The main outcome measured is the change in kidney function eGFR slope from the start of treatment to week 108. Secondary outcomes include changes in albuminuria, kidney failure events, mortality, cardiovascular events, safety, and quality of life. The trial plans long-term follow-up and safety monitoring over several years.

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