FINERENONE (KERENDIA) Meets Primary Endpoint in FIND‑CKD

Bayer reported that the Phase III FIND‑CKD study met its predefined primary endpoint, describing a statistically significant improvement versus placebo in estimated glomerular filtration rate (eGFR) slope from baseline to Month 32 among adults with chronic kidney disease without diabetes randomized to finerenone (KERENDIA) or placebo.

The company described the endpoint as an eGFR-slope measure assessed over 32 months. The announcement provides a high-level summary of efficacy and safety statements and notes that FIND‑CKD data will be presented at an upcoming scientific conference.

Bayer described FIND‑CKD as an international Phase III trial enrolling more than 1,500 adults with non-diabetic CKD across multiple etiologies, with examples including hypertension and chronic glomerulonephritis. Patients were randomized to receive finerenone at 10 mg or 20 mg, with dosing based on serum potassium levels and eGFR, or to control, on top of individually tolerated maximum labeled doses of renin-angiotensin system (RAS)-blocking therapy. Background therapy was characterized as standard of care, with RAS blockade specified as the foundational component in the study design.

For the primary efficacy outcome, Bayer stated that results showed a statistically significant improvement versus placebo in eGFR slope. On safety, Bayer stated that the safety profile of finerenone in FIND‑CKD was consistent with its established safety profile. The release listed prespecified safety endpoints as the occurrence of treatment-emergent adverse events, treatment-emergent serious adverse events, and hyperkalemia adverse events.

Bayer said it anticipates submitting the FIND‑CKD data to the U.S. Food and Drug Administration to extend KERENDIA’s indication to patients with non-diabetic CKD; the announcement did not specify a submission timeline. The company also positioned FIND‑CKD as the largest Phase III study to date focused on non-diabetic CKD and described the result as the fifth consecutive Phase III trial in the KERENDIA program to meet its primary endpoint.

Key Takeaways:

• Bayer reported that Phase III FIND‑CKD met its predefined primary endpoint in adults with non-diabetic CKD, describing a statistically significant improvement versus placebo in eGFR slope from baseline to Month 32.
• The announcement reported statistical significance without releasing numerical effect estimates, and Bayer said fuller data will be presented at an upcoming scientific conference.
• Bayer characterized safety as consistent with the established finerenone profile, listed prespecified safety endpoints (treatment-emergent adverse events, treatment-emergent serious adverse events, and hyperkalemia adverse events), and stated an intention to submit data to the U.S. FDA for a non-diabetic CKD indication extension.