Phase III study FIDELIO-DKD of BAY 94 8862 meets primary endpoint in diabetic kidney disease.- Bayer

The Phase III study FIDELIO-DKD evaluating the efficacy and safety of BAY 94 8862 (finerenone), from Bayer, versus placebo when added to standard of care for chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), has met its primary endpoint. The results show that finerenone delayed the progression of CKD by reducing the combined risk of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) greater than or equal to 40 percent from baseline over a period of at least four weeks, or renal death.

Finerenone also reduced the risk of the key secondary endpoint, a composite of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization. The clinical data from FIDELIO-DKD will be presented at an upcoming scientific meeting.

The FIDELIO-DKD study is part of the largest Phase III clinical trial program to date in CKD, which enrolled 13,000 patients across a broad range of disease severity, including those with early kidney damage and more advanced stages of kidney disease. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D. The study included approximately 5,700 patients from more than 1,000 sites across 48 countries worldwide.