The phase 3 FIGARO-DKD study evaluating finerenone, a nonsteroidal selective mineralocorticoid receptor antagonist, for the reduction of cardiovascular (CV) morbidity and mortality in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) met its primary endpoint.
FIGARO-DKD is a multicenter, randomized, double-blind, placebo-controlled study (ClinicalTrials.gov: NCT02545049) that compared the efficacy and safety of finerenone to placebo in addition to standard of care in approximately 7400 patients with CKD and T2D. Patients were randomly assigned to receive finerenone 10mg or 20mg orally once daily or placebo. Standard of care included blood glucose lowering therapies, as well as angiotensin-converting enzyme inhibitor or angiotensin receptor blocker therapy at maximum tolerated doses.
Findings showed that treatment with finerenone significantly reduced the composite risk of time to first occurrence of CV death and non-fatal CV events (myocardial infarction, stroke, or hospitalization for heart failure). Additional study data will be presented at an upcoming scientific meeting.
“Up to 40% of people with type 2 diabetes develop chronic kidney disease, and they are at high risk of experiencing cardiovascular events, as well as progressing to kidney failure,” said Prof. Luis M. Ruilope, Professor at the Public Health and Preventative Medicine department of the Autonoma University and co-principal investigator of the FIGARO-DKD trial. “The FIGARO-DKD study delivers important insights into the potential effects on cardiovascular outcomes of finerenone in the management of people with chronic kidney disease and type 2 diabetes.”
In January 2021, the Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for finerenone for the treatment of CKD in patients with T2D. The NDA was supported by data from the phase 3 FIDELIO-DKD study (ClinicalTrials.gov: NCT02540993).
“We are pleased to see that the FIGARO-DKD data further support evidence generated in the FIDELIO-DKD trial with respect to reducing the risk of the composite of cardiovascular death and non-fatal cardiovascular events or outcomes in patients with chronic kidney disease and type 2 diabetes,” said Dr Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development.
Compared with the FIDELIO-DKD study, the FIGARO-DKD trial included more patients with earlier stage CKD and T2D.
Bayer’s finerenone meets primary endpoint in phase III FIGARO-DKD cardiovascular outcomes study in Patients with chronic kidney disease and type 2 diabetes. [press release]. Whippany, NJ: Bayer; May 10, 2021.