The investigational drug finerenone, a non-steroidal selective mineralocorticoid receptor antagonist (MRA), delays the progression of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus, Bayer announced in a news release.
In the phase 3 FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) study, finerenone (10 or 20 mg orally once daily) reduced the combined endpoint of time to first occurrence of kidney failure, a 40% or greater reduction in estimated glomerular filtration rate (eGFR) over 4 or more weeks, or renal death, compared with placebo. Both groups received standard of care, including blood glucose-lowering therapies and a maximum tolerated dose of renin-angiotensin system (RAS)-blocking therapy, such as angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs).
“The rate of decline in kidney function among patients with CKD and type 2 diabetes (T2D) under ideal clinical trial circumstances is approximately 2-fold normal age-related decline. Therefore, we clearly need additional medications to slow loss of kidney function,” principal investigator George L. Bakris, MD, of the American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine in Chicago told Renal & Urology News. “Currently available mineralocorticoid receptor antagonists have a clear renoprotective role; however, have hyperkalemia as a limiting factor in clinical practice. Finerenone has been shown to have an acceptable safety profile in phase 2 clinical trials.”
Finerenone also reduced the risk for a key secondary endpoint, a composite of time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization.
Unlike other agents that have slowed CKD progression in patients with type 2 diabetes, finerenone has shown minimal effect on blood pressure in phase 2 studies, Dr Bakris noted. “Finerenone is not believed to work via hemodynamic effects but rather by targeting inflammation and fibrosis caused by mineralocorticoid receptor overactivation, a currently unaddressed driver of CKD progression in type 2 diabetes,” he stated.
“Finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor antagonist to demonstrate renal and cardiovascular benefits in patients with CKD and T2D.”
The FIDELIO-DKD study included approximately 5700 patients from more than 1000 sites across 48 countries worldwide. The full Phase 3 data will be presented at an upcoming scientific meeting, according to Bayer, which funded the study.
Bayer’s finerenone meets primary endpoint in Phase III FIDELIO-DKD renal outcomes study in patients with chronic kidney disease and type 2 diabetes [news release]. Whippany, NJ: Business Wire; July 9, 2020.