WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer will present detailed results from the Phase III FIDELIO-DKD study assessing the use of the investigational drug finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) during scientific sessions of the upcoming American Society of Nephrology’s (ASN) Kidney Week, October 22-25, 2020. Additional data evaluating use of finerenone will also be presented.
The FIDELIO-DKD study, which evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with CKD and T2D, is the first large contemporary positive outcomes study in patients with CKD and T2D with a primary composite endpoint exclusively consisting of kidney-specific outcomes. Bayer announced earlier this year that FIDELIO-DKD met its composite primary renal endpoint and its composite key secondary cardiovascular endpoint.
Full data from the FIDELIO-DKD study will be presented as part of the live-streamed, late-breaker oral abstract session High-Impact Clinical Trials:
- “Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes” – October 23, 2020, 10:30 –10:45 am (EDT) (Abstract FR-OR51)
Additional scientific presentations include:
About the Finerenone Phase III Clinical Program
Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist.1 The Phase III clinical program with finerenone in CKD and T2D is the largest Phase III clinical trial program to date in CKD and T2D having 13,000 randomized patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease. The clinical program comprises two studies (FIDELIO-DKD and FIGARO-DKD), evaluating the effect of finerenone versus placebo in addition to the standard of care in both renal and cardiovascular outcomes.
FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study that investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D from more than 1,000 sites across 48 countries worldwide.
FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) is still ongoing and is investigating the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in Europe, Japan, China and the U.S.
Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (New York Heart Association class II-IV) with a left ventricular ejection fraction of ≥40%. The primary objective of the study is to demonstrate superiority of finerenone over placebo in