The phase III study FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) evaluating the efficacy and safety of finerenone vs. placebo when added to standard of care met its primary endpoint in patients with chronic kidney disease (CKD) and type 2 diabetes. Finerenone significantly reduced the composite of time to first occurrence of CV death or non-fatal CV events (MI, stroke, or HF hospitalization) compared to placebo.

The FIDELIO-DKD trial was the first phase III trial to report outcomes and the difference with this first trial is that FIGARO-DKD included more patients with earlier stage DKD.

FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven phase III trial examining the effect of finerenone versus placebo in patients with DKD. It enrolled ~7400 patients, who were randomized to finerenone 10 mg or 20 mg orally once daily or placebo in addition to standard of care. The FIGARO-DKD is part of a larger clinical trial program in patients with DKD, across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease.

Marketing authorization in the US and the EU for finerenone is currently under review. Results from FIGARO-DKD will be presented at an upcoming meeting.

Source: press release Bayer, May 10, 2021