Bayer initiates phase III FIND-CKD study for finerenone in patients with non-diabetic CKD.
The primary objective of the study is to demonstrate superiority of finerenone over placebo in delaying the progression of kidney disease in these patients.
The primary outcome measure is the mean rate of change in kidney function over time (estimated glomerular filtration rate, eGFR slope) from baseline to month 32.
“Finerenone has been studied so far in more than 13,000 patients through the comprehensive Phase III clinical trial program in chronic kidney disease and type 2 diabetes, which demonstrated positive kidney and cardiovascular outcomes for finerenone versus placebo on top of standard of care,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for new treatments to delay disease progression.”
The planned Phase III FIND-CKD study will investigate finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). Patients will be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).
The initiation of the Phase III FIND-CKD study (FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease) builds upon the robust Phase III results from the FIDELIO-DKD and FIGARO-DKD studies which evaluated the effects of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes in patients with CKD and T2D. Based on these findings, and since the beneficial kidney effect of finerenone observed in previous studies was independent of the glycemic state and was shown in a related population, FIND-CKD will investigate the effect of finerenone in patients with non-diabetic etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys).
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