Bayer announced the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled phase III study for an investigational new use of Kerendia (finerenone) in addition to guideline-directed therapy, on the progression of chronic kidney disease (CKD) in patients with nondiabetic CKD. The primary objective of the study is to demonstrate superiority of finerenone over placebo in delaying the progression of CKD 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.

“In 2017, an alarming 1.2 million people died from chronic kidney disease worldwide. Although diabetes is well-recognized as a leading cause of chronic kidney disease globally, a substantial proportion of the global burden is nondiabetic in origin and attributable to other causes, such as hypertension. To improve outcomes, there is an urgent need for new treatments,” said Hiddo L. Heerspink, professor of clinical trials and personalized medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and co-chair of the study’s executive committee. “If successful, this study could be of great significance to those living with chronic kidney disease globally.”

Kerendia – a nonsteroidal mineralocorticoid receptor antagonist (MRA) – was approved in the United States on July 9, 2021, to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes (T2D).

“Kerendia has been studied so far in more than 13,000 patients through the comprehensive phase III clinical trial program investigating kidney and cardiovascular outcomes in chronic kidney disease associated with type 2 diabetes, which demonstrated efficacy 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 Kerendia to investigate a nondiabetic 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 nondiabetic CKD etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). Patients will be randomized to receive either finerenone 10 mg or 20 mg or placebo on top of individually tolerated optimized doses of a renin-angiotensin system-blocking therapy such as an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.