KERENDIA® (Finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease

Key Takeaways

• FIND‑CKD met primary endpoint, improving eGFR slope vs placebo
• Largest Phase III trial for non‑diabetic CKD, >1,500 patients
• Fifth consecutive Phase III finerenone study achieving primary success
• Bayer plans FDA submission to broaden Kerendia indication
• Safety profile remained consistent with prior finerenone data

Summary

Bayer announced that Kerendia® (finerenone) met its primary endpoint in the Phase III FIND‑CKD trial, showing a statistically significant slowing of eGFR decline versus placebo in non‑diabetic chronic kidney disease patients. The study enrolled over 1,500 participants and represents the fifth consecutive Phase III finerenone trial to achieve its primary goal. Results will be presented at an upcoming scientific conference, and Bayer intends to file an FDA supplemental application to extend the drug’s indication. Kerendia’s safety profile remained consistent with earlier studies.

Pulse Analysis

Chronic kidney disease remains a silent epidemic, affecting roughly 850 million people worldwide, with non‑diabetic forms comprising more than half of cases. Traditional renin‑angiotensin blockade slows progression but does not halt it, leaving a therapeutic gap that mineralocorticoid receptor antagonists aim to fill. Finerenone, a non‑steroidal MR antagonist, offers selective receptor blockade, reducing inflammation and fibrosis in both heart and kidney tissue, positioning it as a promising adjunct to standard of care.

The FIND‑CKD trial enrolled over 1,500 adults with diverse non‑diabetic CKD etiologies, randomizing them to finerenone 10 mg or 20 mg versus placebo on top of optimal ACE‑inhibitor or ARB therapy. The primary efficacy metric—annual eGFR slope from baseline to month 32—showed a statistically significant advantage for finerenone, confirming its ability to decelerate renal function loss. Importantly, adverse events, including hyperkalaemia, mirrored the safety experience observed in diabetic CKD studies, reinforcing the drug’s tolerability across patient groups.

Regulatory and commercial implications are substantial. Bayer’s planned FDA supplemental submission could expand Kerendia’s label to encompass non‑diabetic CKD, unlocking a market of tens of millions of patients and diversifying its cardiovascular‑renal franchise. The data also bolster the broader FINEOVATE program, supporting future combination studies and potential positioning of finerenone as a standard adjunct in CKD management. Investors and clinicians alike will watch the upcoming conference presentation for detailed subgroup analyses that could further refine treatment algorithms.