Finerenone Proves CKD Benefit Extends Beyond Diabetes in FIND-CKD

Bayer has announced the phase 3 FIND-CKD trial evaluating finerenone (Kerendia) in adult patients with nondiabetic chronic kidney disease (CKD) met its primary endpoint, demonstrating a statistically significant improvement in eGFR slope versus placebo over 32 months.

In their March 16, 2026 announcement, the company indicated it plans to submit the data to the US Food and Drug Administration (FDA) to seek a label expansion into this patient population, which would represent the broadest application of the agent to date across a CKD program now spanning more than 20,000 patients in phase 3 trials.^1,2

“Patients with chronic kidney disease have substantial risk for cardiovascular events and kidney failure, so new treatments are needed to help slow kidney disease progression and improve outcomes,” said Hiddo L. Heerspink, PharmD, PhD, professor of Clinical Trials and Personalized Medicine, clinical trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and cochair of the study’s Executive Committee.¹ “The FIND-CKD topline results are encouraging because they now provide evidence for finerenone in a non-diabetic chronic kidney disease population, on top of its established evidence in diabetic chronic kidney disease.”

FIND-CKD Design and Primary Results

FIND-CKD (NCT05047263) was a randomized, double-blind, placebo-controlled phase 3 trial enrolling more than 1500 adults with non-diabetic CKD, including patients with hypertension-related disease and chronic glomerulonephritis. Patients were randomized to receive finerenone 10 mg or 20 mg once daily, dosed based on serum potassium levels and eGFR, or placebo, added to individually tolerated maximum labeled doses of a RAS-blocking therapy, either an ACE inhibitor or an ARB.¹

The primary endpoint was the mean annual rate of change in eGFR from baseline to month 32, a validated surrogate endpoint for kidney disease progression. Finerenone demonstrated a statistically significant improvement in eGFR slope compared with placebo, with a safety profile consistent with the agent's established record across prior studies. Full efficacy and safety data are expected to be presented at an upcoming scientific conference.¹

Finerenone’s Expanding Indication Profile

According to Bayer, FIND-CKD represents the fifth consecutive positive phase 3 trial in the finerenone program and the largest phase 3 study to date focused specifically on non-diabetic CKD.

Finerenone first received FDA approval in 2021 for adults with CKD associated with type 2 diabetes, based on findings from the pivotal FIDELIO-DKD and FIGARO-DKD trials. Those studies established the agent's ability to reduce risk of cardiovascular death, hospitalization for heart failure, non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in patients with diabetic kidney disease, forming the clinical foundation for subsequent development.^1,2

From this foundation, the program has expanded in two directions simultaneously. In heart failure, the phase 3 FINEARTS-HF trial supported FDA approval in July 2025 for heart failure with left ventricular ejection fraction of 40% or higher, extending finerenone's reach beyond CKD into a second major cardiorenal indication.^1,2

In parallel, the CKD program has pushed further into non-diabetic populations. The phase 3 FINE-ONE trial, presented at ASN Kidney Week 2025, demonstrated finerenone produced a 25% relative reduction in urine albumin-to-creatinine ratio versus placebo over 6 months in patients with type 1 diabetes and CKD. FINE-ONE enrolled 242 participants across nine countries, and its safety findings were consistent with prior studies. Bayer is pursuing separate regulatory submissions for this population as well.²

FIND-CKD now extends the non-diabetic CKD evidence base further, enrolling patients across a range of underlying etiologies and over a longer 32-month follow-up period than FINE-ONE.

“The FIND‑CKD findings mark the fifth consecutive Phase III trial in the KERENDIA clinical development program to meet its primary endpoint and represent a major milestone for people living with non-diabetic chronic kidney disease,” said Carolina Aldworth, MD, MSc, executive medical director at Bayer.¹ “When considered alongside the growing evidence base, this important trial adds to our understanding of KERENDIA across multiple patient populations with heart and kidney diseases.”

References:

Bayer. KERENDIA® Meets Primary Endpoint. Bayer.com. Published March 16, 2026. Accessed March 16, 2026. https://www.bayer.com/en/us/news-stories/kerendiar-meets-primary-endpoint

Campbell P. FINE-ONE: Finerenone Proves Benefit in Type 1 Diabetes and CKD. Hcplive.com. Published November 6, 2025. Accessed March 16, 2026. https://www.hcplive.com/view/fine-one-finerenone-proves-benefit-in-type-1-diabetes-and-ckd