Finerenone Shows Kidney Benefit in Non-Diabetic CKD in Phase III FIND-CKD Trial
Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.
The Phase III FIND-CKD trial investigating finerenone (Kerendia) in adults with non-diabetic chronic kidney disease has met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in kidney function decline compared to placebo. The results showed finerenone achieved a significant improvement versus placebo in the estimated glomerular filtration rate (eGFR) slope from baseline to month 32, a validated surrogate endpoint for slowing kidney disease progression. Bayer plans to submit the data to the U.S. Food and Drug Administration to extend the indication of Kerendia to this patient population.
FIND-CKD is the fifth consecutive Phase III clinical trial where finerenone met its primary endpoint and represents the largest Phase III study to date focused on non-diabetic CKD. The trial enrolled more than 1,500 patients with non-diabetic CKD across various etiologies, including hypertension and chronic glomerulonephritis. Patients were randomized to receive either finerenone 10 mg or 20 mg, based on serum potassium levels and eGFR, or placebo, added to individually tolerated maximum labeled doses of renin-angiotensin system-blocking therapy.
The safety profile of finerenone in the FIND-CKD study was consistent with its well-established safety profile. The clinical data from FIND-CKD will be presented at an upcoming scientific conference.
Approximately 850 million people worldwide are living with chronic kidney disease, and more than half of them have non-diabetic CKD. Non-diabetic CKD can have a range of etiologies, of which the most common include hypertension and glomerulonephritis. Chronic kidney disease linked to hypertension is the second most common cause of kidney failure. Patients with advanced non-diabetic CKD face a significantly increased risk for a fatal cardiovascular event, about 2.6 times higher than that of the general population without CKD.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist and the first drug targeting the mineralocorticoid receptor pathway that in five pivotal Phase III studies has demonstrated cardiovascular and/or kidney benefits in patients with heart failure with left ventricular ejection fraction ≥40%, patients with CKD associated with type 2 diabetes, patients with CKD associated with type 1 diabetes, and patients with non-diabetic CKD.
Finerenone is already marketed as Kerendia and approved for the treatment of adult patients with chronic kidney disease associated with type 2 diabetes in more than 100 countries worldwide, including in China, Europe, Japan, and the U.S. In the U.S. and in Japan and some other markets, finerenone is also approved for the treatment of heart failure with left ventricular ejection fraction ≥ 40%.