ENPNewswire-July 10, 2020--Bayer's finerenone meets primary endpoint in Phase III FIDELIO-DKD renal outcomes study in patients with chronic kidney disease and type 2 Diabetes
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Release date- 09072020 - Berlin - Bayer's Phase III study FIDELIO-DKD evaluating the efficacy and safety of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D)(1) has met its primary endpoint.
The results show that the investigational drug finerenone delayed the progression of CKD by significantly 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% from baseline over a period of at least four weeks, or renal death. Finerenone significantly reduced the risk of the key secondary outcome, a composite of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization.
The FIDELIO-DKD study is part of the largest Phase III clinical trial program to date in CKD and T2D, 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. Patients were randomized to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of RAS-blocking therapy such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).
The clinical data from FIDELIO-DKD will be presented at an upcoming scientific meeting. Bayer will discuss the data with health authorities regarding the submission of marketing authorization application.
Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block many of the harmful effects of mineralocorticoid receptor (MR) overactivation. MR overactivation is a major driver of kidney and heart damage.