Phase III FIDELIO-DKD study of BAY 94 8862 shows benefits in chronic kidney disease + T2D.- Bayer

Bayer announced that detailed results from the FIDELIO-DKD Phase III study demonstrated that the investigational drug BAY 94 8862 (finerenone) slowed the progression of chronic kidney disease (CKD) in patients with CKD and type 2 diabetes (T2D) compared to placebo. In the study, finerenone significantly reduced the risk of the composite primary endpoint of time to 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 by 18 percent (relative risk reduction, HR 0.82 [95 percent CI, 0.73-0.93; p=0.0014]) over a median duration of follow-up of 2.6 years when added to maximum tolerated dose of guideline-directed therapy. At 36 months, the number needed to treat to prevent a primary composite endpoint event was 29 [95 percent CI 16-166]. FIDELIO-DKD 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. The findings from the FIDELIO-DKD study, which is part of the largest Phase III clinical trial program to date in CKD and T2D were presented at the virtual American Society of Nephrology’s (ASN) Kidney Week 2020, October 22 – 25, and simultaneously published in the New England Journal of Medicine.See: "Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes." George L. Bakris et al. NEJM October 23, 2020 DOI: 10.1056/NEJMoa2025845