Bayer announced that finerenone (KERENDIA) met the primary endpoint of its Phase III FIND-CKD study in patients with non-diabetic chronic kidney disease, demonstrating a statistically significant improvement in eGFR slope versus placebo over 32 months. The result extends the clinical evidence for finerenone beyond diabetic CKD populations and into a disease segment where no targeted therapy beyond renin-angiotensin system blockade currently holds regulatory approval.
Trial specifics
The FIND-CKD study (NCT05047263) was a Phase III, randomized, placebo-controlled trial enrolling more than 1,500 adults with non-diabetic CKD, including patients with underlying hypertension and chronic glomerulonephritis. Participants were randomized to receive finerenone at 10mg or 20mg, dosed according to baseline serum potassium and eGFR, or placebo. Both arms received individually tolerated maximum labeled doses of a renin-angiotensin system blocker such as an ACE inhibitor or angiotensin II receptor blocker. The primary endpoint was the mean annual rate of change in estimated glomerular filtration rate from baseline to Month 32, a surrogate endpoint the US FDA has recognized as a basis for drug approval in CKD. According to the company, finerenone achieved a statistically significant improvement in this eGFR slope measure compared with placebo. Bayer did not disclose the magnitude of the between-group difference, the p-value, or detailed subgroup analyses. The safety profile, the company said, was consistent with the established profile of finerenone, which in prior trials included hyperkalemia, hypotension, and hyponatremia as the most frequently reported adverse reactions.
Bayer said it plans to present the full FIND-CKD study results at an upcoming scientific conference and anticipates submitting the data to the US FDA to seek an expanded indication for finerenone in non-diabetic CKD. KERENDIA is currently approved by the US FDA for two indications: reducing the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with type 2 diabetes, an approval granted in 2021; and for the treatment of heart failure with left ventricular ejection fraction of 40% or greater, approved in July 2025. FIND-CKD is the fifth consecutive Phase III trial in the FINEOVATE program in which finerenone met its primary endpoint, following FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, and FINE-ONE.
Research context
Finerenone is a non-steroidal mineralocorticoid receptor antagonist. The mineralocorticoid receptor, when overactivated by aldosterone, drives inflammatory and fibrotic processes in kidney and cardiac tissue that contribute to organ damage and disease progression. Unlike steroidal MR antagonists such as spironolactone and eplerenone, finerenone was designed to selectively block this receptor with a different binding profile intended to reduce the incidence of hormonal side effects while retaining anti-fibrotic and anti-inflammatory activity. In CKD, sustained MR overactivation accelerates tubular injury and glomerulosclerosis even in patients already receiving RAS blockade, providing the rationale for adding an MR antagonist to standard therapy.