Phase III FIND‑CKD Results Show Bayer’s KERENDIA® (finerenone) Improved eGFR Slope and Reduced Risk of a Composite Kidney-Cardiovascular Outcome in Adults with Non‑Diabetic Chronic Kidney Disease

Investigational results from FIND-CKD provide full efficacy and safety data and is the fifth consecutive Phase III clinical trial where KERENDIA met its primary endpoint—adding to a clinical trial program of more than 20,000 patients across multiple patient populations with heart and kidney diseases, now with additional data in a different patient population.¹

KERENDIA is currently approved by the FDA for use in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), as well as adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%.²

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer

Summary

Bayer announced today full results from the Phase III FIND-CKD trial investigating KERENDIA^® (finerenone) in adults with non-diabetic chronic kidney disease (nd-CKD) who were also receiving background standard of care. In the trial, KERENDIA met the primary endpoint by showing a significant reduction in the rate of kidney disease progression, as measured by estimated glomerular filtration rate (eGFR) slope (mean annual change from baseline to month 32), compared with placebo.¹ KERENDIA also showed a statistically significant reduction in the risk of a secondary composite kidney-cardiovascular endpoint, which included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure, or cardiovascular death, versus placebo.¹

These results were presented as a late breaker at the 63rd European Renal Association (ERA) Congress on June 5^th, 2026, in Glasgow, Scotland, and were simultaneously published in the New England Journal of Medicine.

Key Facts

• KERENDIA met the primary endpoint by showing a significant reduction in the rate of kidney disease progression, as measured by eGFR slope (mean annual change from baseline to month 32), compared with placebo. ¹
• KERENDIA also showed a statistically significant reduction in the risk of a secondary composite kidney-cardiovascular endpoint, which included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure, or cardiovascular death, versus placebo. ¹
• The safety profile of KERENDIA was consistent with prior Phase III studies. The incidence of serious adverse events was similar between the KERENDIA and placebo groups (20.9% and 21.2%, respectively). ¹

Why the FIND-CKD Results Matter

CKD is a progressive disease that can lead to cardiovascular complications and kidney failure.³

It represents a major global health challenge affecting 850 million people worldwide as the ninth leading cause of death.^4,5 Between 50-70% of cases are in non-diabetic adults.⁶ In the U.S., more than 35 million people are estimated to have CKD.⁷

“Chronic kidney disease is underrecognized and underdiagnosed in the United States, leaving many patients at risk for kidney failure and cardiovascular events.⁷ Despite available treatments, there remains a critical unmet need,”⁶ said Rajiv Agarwal, MD, Professor Emeritus of Medicine at Indiana University School of Medicine and a member of the study’s Executive Committee. “The FIND-CKD results provide important Phase III data on finerenone’s potential for adults living with non-diabetic chronic kidney disease.”

FIND-CKD Clinical Trial Design¹

FIND-CKD is a multicenter, double-blind, Phase III trial investigating KERENDIA versus placebo in 1,584 adults with nd-CKD including etiologies such as hypertension and chronic glomerulonephritis (inflammation of the kidneys’ blood filters).

Participants were randomized to receive either KERENDIA or placebo in addition to standard of care, which included maximally tolerated labeled doses of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).

FIND-CKD Clinical Trial Results¹

KERENDIA met the primary efficacy endpoint by showing a statistically significant improvement in eGFR slope compared with placebo. The mean annual rate of eGFR decline from baseline to month 32 was −3.3 mL/min/1.73 m²/year with KERENDIA and −4.0 mL/min/1.73 m²/year with placebo, corresponding to a between-group difference of 0.7 mL/min/1.73 m²/year (95% CI, 0.3 to 1.1; p<0.001). eGFR slope is a validated surrogate endpoint for kidney disease progression.

As a key secondary endpoint, KERENDIA showed a statistically significant reduction in the risk of a prespecified composite kidney-cardiovascular outcome compared with placebo (hazard ratio 0.77; 95% CI, 0.60 to 0.99; p=0.043). The composite outcome included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure, or cardiovascular death.

Additionally, in an exploratory analysis, a greater proportion of participants receiving KERENDIA achieved a ≥30% reduction from baseline in urine albumin-to-creatinine ratio (UACR) at month 6 compared with placebo (56.0% vs 24.4%; odds ratio 3.99; 95% CI, 3.22 to 4.95).

The incidence rate of treatment-emergent adverse events (TEAEs) was 68.3% with KERENDIA and 65.4% with placebo. The rate of treatment-emergent serious adverse events (TESAEs) was 20.9% with KERENDIA and 21.2% with placebo. Hyperkalemia, an adverse event of special interest (AESI), was observed more frequently with KERENDIA (17%) compared to placebo (13.3%). The rate of serious hyperkalemia events and hyperkalemia leading to hospitalization or study discontinuation was low in both groups (˂1% and ˂2%, respectively).

Bayer Executive Commentary

“The FIND-CKD data mark another key milestone reinforcing KERENDIA’s potential to reduce the risk of kidney and cardiovascular events, adding to the findings from our clinical trial program of more than 20,000 patients across multiple populations with heart and kidney diseases,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. "We're proud these findings were recognized prominently at ERA and simultaneously published in NEJM, reflecting the importance of this trial and its potential impact on the non-diabetic CKD community.”

Glomerular Disease Prespecified Subanalysis⁸

A prespecified exploratory analysis of FIND-CKD, simultaneously published in the Journal of the American Medical Association, evaluated the efficacy and safety of KERENDIA in people with investigator-reported glomerular disease etiologies including IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), membranous nephropathy and membranoproliferative glomerulonephritis (MPGN).

In this subanalysis, KERENDIA showed an improvement in eGFR slope compared with placebo across glomerular disease subtypes, with a total eGFR slope difference through month 32 of 0.73 mL/min/1.73 m²/year (95% CI, 0.22 to 1.24).

KERENDIA was also associated with improvements in UACR and a lower risk of a prespecified composite kidney outcome of kidney failure or sustained decline in eGFR compared with placebo.

The incidence rate of serious adverse events was 19.5% with KERENDIA and 21.4% with placebo, while the rate of serious hyperkalemia was 0.9% for both.

About KERENDIA’s Clinical Trial Program

KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 12 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL).

• The MOONRAKER program includes FINEARTS-HF,⁹ the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,¹⁰ CONFIRMATION-HF,¹¹ and FINALITY-HF,¹² as well as the ongoing studies FIORE¹³ and FIORELLO.¹⁴
• The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD,¹⁵ FIGARO-DKD,¹⁶ FINE-ONE¹⁷ and FIND-CKD¹⁸ as well as the ongoing investigational pediatric studies, FIONA¹⁹ and FIONA-OLE.²⁰

About KERENDIA²

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.

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 INFORMATION²

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 m² 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%).²¹ 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.

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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.

^____________________ ^1 Heerspink HJL, et al. N Eng J Med. 2026; doi: 10.1056/NEJMoa2604625

^2 KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc: August 2025

^3 National Kidney Foundation. Chronic kidney disease (CKD). National Kidney Foundation. Published 2023. https://www.kidney.org/kidney-topics/chronic-kidney-disease-ckd

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

^5 Mark P, Stafford L, Grams M et al. Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023 The Lancet, 2025; 406, 2461-2482

^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 June 2, 2026. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

^8 Neuen BL, et al. JAMA. 2026; doi: 10.1001/jama.2026.9923

^9 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 June 2, 2026

^10 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 June 2, 2026.

^11 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 June 2, 2026.

^12 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 June 2, 2026.

^13 A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction (FIORE). Clinical trial registration No. NCT07188805. https://clinicaltrials.gov/study/NCT07188805. Accessed June 2, 2026.

^14 A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction (FIORELLO). Clinical trial registration No. NCT07192952. https://clinicaltrials.gov/study/NCT07192952. Accessed June 2, 2026.

^15 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 June 2, 2026.

^16 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 June 2, 2026.

^17 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 June 2, 2026.

^18 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 June 2, 2026.

^19 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 June 2, 2026.

^20 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 June 2, 2026.

^21 Data on file.

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