Author: pr-moritz
Last saved by: Sascha Buhr
Company: Bayer
Document comments: V-2024-03-05

Not intended for U.S. and UK Media

Finerenone meets primary endpoint in pivotal Phase III FIND-CKD study in patients with non-diabetic chronic kidney disease
•	Finerenone significantly delayed kidney disease progression in patients with non-diabetic chronic kidney disease (CKD) versus placebo in addition to standard of care
•	FIND-CKD, the largest Phase III study to date focused on non-diabetic CKD, investigated finerenone in a broad patient population spanning different etiologies of non-diabetic CKD, adding to the positive data and breadth of evidence of finerenone in CKD associated with diabetes
•	There are limited treatment options available for patients living with non-diabetic CKD, and the unmet need is high for new treatments to delay kidney disease progression and reduce cardiovascular risk 
•	FIND-CKD is the fifth completed Phase III study to report positive results with finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), which so far was studied in more than 20,000 patients across multiple patient populations with chronic kidney disease and/or heart failure

Berlin, March 16, 2026 – The Phase III study FIND-CKD, evaluating the efficacy and safety of finerenone (Kerendia™) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD), has met its primary endpoint. The results showed that finerenone reduced kidney function decline by achieving a statistically significant and clinically meaningful improvement versus placebo in addition to standard of care in 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 is a validated surrogate endpoint for clinical kidney outcomes and is used as a predictive metric for the risk of kidney failure. Finerenone was well-tolerated in the FIND-CKD study, which is consistent with the well-established safety profile of finerenone. The clinical data from FIND-CKD will be presented at an upcoming scientific conference, and Bayer plans to submit the data to health authorities to extend the indication of Kerendia™ to this patient population. 

Approximately 850 million people worldwide are living with chronic kidney disease (CKD) and more than half of them have non-diabetic CKD. Non-diabetic CKD can have a range of etiologies, of which the most common include hypertension and glomerulonephritis (including immunoglobulin A nephropathy (IgAN)). Chronic kidney disease linked to hypertension is the second most common cause of kidney failure. Worldwide, more than 3.5 million people with kidney failure are treated with dialysis, which is linked to a 5-year survival rate of about 40% after treatment initiation. In addition, patients with advanced non-diabetic CKD face a significantly increased risk for a fatal cardiovascular event, about 2.6 times higher than that of the general population without CKD, which increases further as kidney function declines. Despite the high prevalence and high morbidity and mortality rate, non-diabetic CKD etiologies remain underrepresented in international clinical practice guidelines.

“Patients with non-diabetic chronic kidney disease experience a progressive loss of kidney function and are at high risk of kidney failure and cardiovascular disease. 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,” said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine, clinical 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. “The FIND-CKD results are encouraging because they show the benefits of finerenone in preserving kidney function in a dedicated study across several etiologies of non-diabetic chronic kidney disease.” 

“The positive results of the Phase III FIND-CKD study represent an important advancement in the area of non-diabetic chronic kidney disease, regardless of the underlying cause,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “Combined with the overall evidence from the THUNDERBALL chronic kidney disease 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.”

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that in five pivotal Phase III studies has demonstrated cardiovascular and/or kidney benefits, respectively, in patients with HF with left ventricular ejection fraction (LVEF) ≥40%, patients with CKD associated with type 2 diabetes, patients with CKD associated with type 1 diabetes, and patients with non-diabetic CKD. FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD, and investigated finerenone in a broad patient population spanning different etiologies of non-diabetic CKD, adding to the positive data and breadth of evidence of finerenone in CKD associated with diabetes. Finerenone is already marketed as Kerendia™ or, in selected countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan, and the U.S. In the U.S. and in Japan and some other markets, finerenone is also approved for the treatment of heart failure with LVEF ≥ 40%. Applications in HF with LVEF ≥ 40% in additional markets, including China and Europe, are under review. 

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, as well as the ongoing investigator-sponsored, collaborative studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies in paediatric patient populations FIONA, and FIONA-OLE. 

About FIND-CKD
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) investigated 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. Patients were randomized to receive either finerenone 10mg or 20mg or placebo on top of maximum tolerated 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 primary endpoint was the mean annual rate of change in eGFR from baseline to Month 32. Secondary endpoints included a combined cardio-kidney endpoint, which was a composite of kidney failure, sustained ≥57% eGFR decrease, hospitalization for heart failure or cardiovascular death. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs.

About Chronic Kidney Disease 
CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD affects 850 million people worldwide. In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. In 2023, CKD accounted for over 1.4 million deaths, ranking as the ninth leading cause of death. Healthy kidneys act as the body’s filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure. As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain and confusion, trouble focusing, memory problems. Major underlying causes of CKD include diabetes, hypertension, glomerulonephritis such as immunoglobulin A nephropathy, focal segmental glomerulosclerosis and membranous nephropathy.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases 
Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular and kidney diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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