FIND-CKD: Bayer initiates investigation of finerenone for patients with nondiabetic CKD
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Following studies showing the benefits of finerenone for patients with chronic kidney disease and type 2 diabetes, Bayer announced it will now investigate the efficacy of the drug for delaying CKD progression in patients without diabetes.
According to a company press release, FIND-CKD is a multicenter, randomized, double-blind, placebo-controlled phase 3 study in which researchers will evaluate the mean rate of change in eGFR slope from baseline to 32 months.
“Kerendia [finerenone] has been studied so far in more than 13,000 patients through the comprehensive phase 3 clinical trial program investigating kidney and cardiovascular outcomes in chronic kidney disease associated with type 2 diabetes, which demonstrated efficacy for finerenone [vs.] placebo on top of standard of care,” Christian Rommel, PhD, member of the executive committee of Bayer AG’s pharmaceutical division and head of research and development, said in the release. “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 study has enrolled more than 1,500 patients with CKD due to nondiabetic causes, including hypertension and glomerulonephritis, according to the release. All patients will be randomized to receive 10 mg or 20 mg of finerenone or placebo and will also receive “individually tolerated optimized doses” of a renin-angiotensin system-blocking therapy, according to the release.
“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,” Hiddo L. Heerspink, PhD, PharmD, 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 in the Netherlands, and co-chair of the executive committee of the study, said in the release. “If successful, this study could be of great significance to those living with chronic kidney disease globally.”
In July 2021, Kerendia was approved by the FDA 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 and type 2 diabetes.
Reference:
- Bayer: Extends clinical development program for Kerendia (finerenone) with phase III study to investigate use in patients with nondiabetic chronic kidney disease. https://www.businesswire.com/news/home/20210920005126/en/Bayer-Extends-Clinical-Development-Program-for-KERENDIA%C2%AE-finerenone-With-Phase-III-Study-to-Investigate-Use-in-Patients-With-Nondiabetic-Chronic-Kidney-Disease. Published Sept. 20, 2021. Accessed Sept. 21, 2021.