Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Why It Matters

Demonstrating efficacy in non‑diabetic CKD broadens Kerendia’s therapeutic reach and could reshape treatment standards for a large, underserved patient population.

Key Takeaways

• >1,500 non-diabetic CKD patients studied
• Kerendia improved eGFR slope versus placebo
• Primary endpoint achieved with statistical significance
• Data to be presented and filed with regulators
• Review ongoing in China, EU for HF LVEF ≥40%

Pulse Analysis

Chronic kidney disease remains a leading cause of morbidity worldwide, yet therapeutic options outside the diabetic spectrum are limited. Finerenone, a selective mineralocorticoid receptor antagonist, earned FDA approval for diabetic CKD in 2021, leveraging its anti‑inflammatory and antifibrotic properties. The FIND‑CKD trial extends this mechanism to patients without diabetes, addressing a critical gap in nephrology care and signaling a shift toward disease‑modifying strategies that target underlying pathophysiology rather than merely controlling symptoms.

The Phase III study enrolled over 1,500 participants, randomizing them to 10 mg or 20 mg Kerendia or placebo, all on top of guideline‑directed standard of care. The primary endpoint—annualized change in estimated glomerular filtration rate (eGFR) through month 32—showed a statistically significant improvement for Kerendia, indicating a slower trajectory of kidney function loss. Such a result not only satisfies regulatory criteria for efficacy but also offers clinicians a quantifiable tool to preserve renal function, potentially delaying dialysis initiation and reducing healthcare costs associated with end‑stage renal disease.

If regulatory agencies grant approval, Kerendia could capture a sizable market share in the non‑diabetic CKD segment, complementing its existing diabetic indication. The concurrent review of Kerendia/Firialta for heart‑failure patients with preserved ejection fraction in China and the EU further amplifies its commercial potential, positioning Bayer as a leader in cardio‑renal therapeutics. Investors and stakeholders will watch the forthcoming conference presentation and submission dossiers closely, as they will determine the speed and scope of market entry, pricing strategies, and competitive dynamics against emerging SGLT2 inhibitors and other mineralocorticoid antagonists.