Bayer's Finerenone Achieves Primary Endpoint in Phase III FIND-CKD Trial for Non-Diabetic Chronic Kidney Disease
核心洞察
Finerenone demonstrated statistically significant and clinically meaningful improvement in kidney function decline versus placebo in the Phase III FIND-CKD study of over 1,500 patients with non-diabetic chronic kidney disease (搜索).
The study met its primary endpoint by showing reduced kidney function decline through improved estimated glomerular filtration rate (eGFR) slope, a validated surrogate endpoint for clinical kidney outcomes.
This represents the largest Phase III study to date focused on non-diabetic CKD, spanning different etiologies including hypertension (搜索) and glomerulonephritis (搜索), with Bayer (搜索) planning regulatory submissions to extend Kerendia's indication.
Bayer (搜索) announced that its Phase III FIND-CKD study evaluating finerenone (Kerendia™) has successfully met its primary endpoint in patients with non-diabetic chronic kidney disease (搜索) (CKD). The results demonstrated that finerenone reduced kidney function decline by achieving a statistically significant and clinically meaningful improvement versus placebo when added to standard of care.
The primary endpoint measured the estimated glomerular filtration rate (eGFR) slope, defined as the mean annual rate of change in eGFR from baseline to Month 32. The eGFR slope serves as a validated surrogate endpoint for clinical kidney outcomes and functions as a predictive metric for the risk of kidney failure (搜索).
Study Design and Patient Population
FIND-CKD represents the largest Phase III study to date focused on non-diabetic CKD, investigating finerenone in more than 1,500 patients across different etiologies of non-diabetic chronic kidney disease (搜索), including hypertension (搜索) and chronic glomerulonephritis (搜索). Patients were randomized to receive either finerenone 10mg or 20mg or placebo on top of maximum tolerated labeled doses of renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).
Secondary endpoints included a combined cardio-kidney endpoint, comprising a composite of kidney failure (搜索), sustained ≥57% eGFR decrease, hospitalization for heart failure (搜索) or cardiovascular death. Safety endpoints evaluated the occurrence of treatment-emergent adverse events, treatment-emergent serious adverse events, and hyperkalemia adverse events.
Addressing Significant Unmet Medical Need
Approximately 850 million people worldwide are living with chronic kidney disease (搜索), with more than half having non-diabetic CKD. Non-diabetic CKD encompasses various etiologies, with hypertension (搜索) and glomerulonephritis (搜索) (including immunoglobulin A nephropathy (搜索)) being the most common causes. Chronic kidney disease linked to hypertension represents the second most common cause of kidney failure (搜索) globally.
The disease burden is substantial, with more than 3.5 million people with kidney failure (搜索) worldwide receiving dialysis treatment, which carries a 5-year survival rate of approximately 40% after treatment initiation. Patients with advanced non-diabetic CKD face a significantly increased risk for fatal cardiovascular events, approximately 2.6 times higher than the general population without CKD, with risk increasing further as kidney function declines.
"Patients with non-diabetic chronic kidney disease (搜索) experience a progressive loss of kidney function and are at high risk of kidney failure (搜索) and cardiovascular disease (搜索)," said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Co-Chair of the study's Executive Committee. "New treatments that can reduce kidney disease progression are needed to help improve the prognosis of these patients, who have a substantial risk for cardiovascular events and kidney failure which can necessitate dialysis."
Clinical Significance and Safety Profile
Finerenone demonstrated a well-tolerated safety profile in the FIND-CKD study, consistent with the established safety profile of the drug. The positive results span a broad patient population across different etiologies of non-diabetic CKD, adding to the existing evidence base for finerenone in CKD associated with diabetes.
"The positive results of the Phase III FIND-CKD study represent an important advancement in the area of non-diabetic chronic kidney disease (搜索), regardless of the underlying cause," said Dr. Christian Rommel, Global Head of Research and Development at Bayer (搜索)'s Pharmaceuticals Division. "Combined with the overall evidence from the THUNDERBALL chronic kidney disease (搜索) clinical trial program including the pivotal studies FIDELIO-DKD, FIGARO-DKD, and FINE-ONE, these results further strengthen the evidence on the consistent benefits of finerenone in the treatment of patients with chronic kidney disease."
Regulatory and Commercial Implications
Bayer (搜索) plans to present the clinical data from FIND-CKD at an upcoming scientific conference and submit the data to health authorities to extend the indication of Kerendia™ to this patient population. Currently, finerenone is approved as Kerendia™ or Firialta (搜索)™ for the treatment of adult patients with chronic kidney disease (搜索) associated with type 2 diabetes in more than 100 countries worldwide, including China, Europe, Japan, and the United States.
In the United States, Japan, and some other markets, finerenone is also approved for the treatment of heart failure (搜索) with left ventricular ejection fraction ≥ 40%. Applications for heart failure indications in additional markets, including China and Europe, are currently under review.
Mechanism of Action and Development Program
Finerenone is a non-steroidal, selective mineralocorticoid receptor (搜索) antagonist (nsMRA) that blocks harmful effects of mineralocorticoid receptor overactivation. MR overactivation contributes to chronic kidney disease (搜索) progression and cardiovascular damage, which can be driven by metabolic, hemodynamic, inflammatory, and fibrotic factors.
The drug represents the first compound targeting the mineralocorticoid receptor (搜索) pathway that has demonstrated cardiovascular and/or kidney benefits across five pivotal Phase III studies in diverse patient populations, including patients with heart failure (搜索) 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.
The comprehensive clinical study program with finerenone, called FINEOVATE, currently comprises ten Phase III studies with dedicated programs in heart failure (搜索) and chronic kidney disease (搜索). The THUNDERBALL CKD program includes completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, along with ongoing pediatric studies FIONA and FIONA-OLE.