LL schreef op 22 september 2021 10:06:
Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney diseaseThere are limited treatment options available for chronic kidney disease (CKD), and patients often still progress to kidney failure or premature death / The Phase III study FIND-CKD will investigate the effect of finerenone on kidney and cardiovascular outcomes in patients with non-diabetic chronic kidney disease
Berlin, September 20, 2021 – Bayer announced today the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III study to investigate the efficacy and safety of finerenone in addition to guideline-directed therapy, on the progression of chronic kidney disease (CKD) 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.
“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 non-diabetic in origin and attributable to other causes, such as hypertension. To improve outcomes, new treatments that can target kidney-specific disease mechanisms are highly desired,” 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.”
Finerenone is an investigational, non-steroidal, selective mineralocorticoid (MR) antagonist that has been shown in preclinical studies to block harmful effects of MR overactivation. MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. Finerenone has already demonstrated benefits on kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes in two completed Phase III studies, FIDELIO-DKD and FIGARO-DKD.
“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).
In July, finerenone was approved under the brand name Kerendia® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study for patients with CKD and T2D. Finerenone has also been submitted for marketing authorization in the European Union (EU) and China, as well as multiple other countries worldwide and these applications are currently under review.
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