KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease

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3:30 AM on Monday, March 16

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WHIPPANY, N.J.--(BUSINESS WIRE)--Mar 16, 2026--

The Phase III study FIND-CKD ( NCT05047263 ) — investigating the efficacy and safety of KERENDIA ® (finerenone) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD) — has met its primary endpoint. 1 The results demonstrated a statistically significant improvement versus placebo in the primary efficacy outcome of estimated glomerular filtration rate (eGFR) slope, defined as the mean annual rate of change from baseline to Month 32, 1 a validated surrogate endpoint for kidney disease progression. 3 The safety profile of KERENDIA in the FIND-CKD study was consistent with its established safety profile. 1

The FIND-CKD clinical trial data will be presented at an upcoming scientific conference. Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to non-diabetic CKD patients.

“Patients with chronic kidney disease have substantial risk for cardiovascular events and kidney failure, so new treatments are needed to help slow kidney disease progression and improve outcomes,” 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 topline results are encouraging because they now provide evidence for finerenone in a non-diabetic chronic kidney disease population, on top of its established evidence in diabetic chronic kidney disease.”

Since 2021, KERENDIA has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received FDA approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) ≥40%. 2

Approximately 850 million people worldwide are living with CKD, and those with non-diabetic CKD represent more than half of these cases. 4,5,6 In the U.S., more than 35 million people are estimated to have CKD. 7 In 2023, CKD accounted for over 1.4 million deaths, ranking as the ninth leading cause of death. 8

“The FIND‑CKD findings mark the fifth consecutive Phase III trial in the KERENDIA clinical development program to meet its primary endpoint and represent a major milestone for people living with non-diabetic chronic kidney disease,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “When considered alongside the growing evidence base, this important trial adds to our understanding of KERENDIA across multiple patient populations with heart and kidney diseases.”

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys. 2 FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD and investigated KERENDIA in a population spanning different etiologies of non-diabetic CKD.

About FIND-CKD
The Phase III FIND-CKD9 study investigated finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic CKD etiologies, of which etiologies included hypertension and chronic glomerulonephritis (inflammation of the kidneys’ blood filters). Patients were randomized to receive either finerenone 10mg or 20mg, based on serum potassium levels and eGFR, 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). The primary endpoint was the mean annual rate of change in eGFR from baseline to 32 months. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs.

About KERENDIA’s Clinical Trial Program
KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF10 as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF, 11CONFIRMATION-HF12 and FINALITY-HF. 13 The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD, 14FIGARO-DKD, 15FINE-ONE16 and FIND-CKD17 as well as the ongoing investigational studies, FIONA18 and FIONA-OLE. 19

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. 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, confusion, trouble focusing and memory problems. Major underlying causes of CKD include diabetes, hypertension and glomerulonephritis such as immunoglobulin A nephropathy, focal segmental glomerulonephritis and membranous nephropathy.

About KERENDIA ® (finerenone) 2

INDICATIONS:
KERENDIA (finerenone) is indicated to reduce the risk of:

sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Hypersensitivity to any component of this product
Concomitant use with strong CYP3A4 inhibitors
Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.

Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed.

Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly . Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m 2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

MOST COMMON ADVERSE REACTIONS:

CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). 20 Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

Please see the Prescribing Information for KERENDIA.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer’s legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys—two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs. With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose.

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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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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1 Data on file.

2 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf. Accessed March 4, 2026

3 Research C for DE and. Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure. FDA. Published online August 20, 2020. https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure

4 Jager KJ, et al. Kidney Int. 2019;96(5):1048-1050.

5 GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. The Lancet. 2018;392(10159):1789-1858

6 Wanner C, et al. BMC Nephrol. 2025;26:1–11. / Webster AC, Nagler EV, Morton RL, Masson P. Chronic kidney disease. Lancet. 2017;389:1238–52.

7 NIDDK. Kidney disease statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. Published 2023. Accessed March 4, 2026. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

8 GBD 2023 Chronic Kidney Disease Collaborators. The Lancet. 2025;406(10518):2461-2482.

9 Heerspink HJL, Agarwal R, Bakris GL, et al. Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial. Nephrol Dial Transplant. 2025;40(2):308-319. doi:10.1093/ndt/gfae132

10 Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/study/NCT04435626 Accessed March 4, 2026

11 A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. https://www.clinicaltrials.gov/study/NCT06008197. Accessed March 4, 2026.

12 A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. https://www.clinicaltrials.gov/study/NCT06024746. Accessed March 4, 2026.

13 A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950. Accessed March 4, 2026.

14 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993. Accessed March 4, 2026.

15 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) Clinical trial registration No. NCT02545049 https://clinicaltrials.gov/study/NCT02545049. Accessed March 4, 2026.

16 A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys’ Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). Clinical trial registration No. NCT05901831. https://www.clinicaltrials.gov/study/NCT05901831. Accessed March 4, 2026.

17 A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. https://www.clinicaltrials.gov/study/NCT05047263. Accessed March 4, 2026.

18 A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. https://www.clinicaltrials.gov/study/NCT05196035. Accessed March 4, 2026.

19 A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283. Accessed March 4, 2026.

20 Data on file.

COR-KER-US-0185-1 3/26

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SOURCE: Bayer

PUB: 03/16/2026 03:30 AM/DISC: 03/16/2026 03:30 AM