- Data from the Phase III FINE-ONE trial, which investigated the safety and efficacy of finerenone versus placebo in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), will be featured at the opening plenary special session
- Two late-breaking analyses from the CONFIDENCE trial in patients with type 2 diabetes (T2D) and CKD, which investigated simultaneous administration of finerenone and a sodium-glucose transport protein 2 inhibitor (SGLT2i), will also be presented
WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer announced today that data from across the KERENDIA® (finerenone) comprehensive clinical trial program will be presented in scientific sessions at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas, November 6–9.
“Up to 30% of Americans living with type 1 diabetes (T1D) are affected by chronic kidney disease (CKD),1,2 which puts them at significant risk for cardiovascular (CV) events and kidney failure despite current standard of care.3 No new treatments have been approved in CKD associated with T1D for more than 30 years,”3 said Carolina Aldworth, M.D., MSc, Executive Director, U.S. Medical Affairs at Bayer. “We are honored that the results of FINE-ONE will be featured at the opening plenary session at ASN, reflecting Bayer’s commitment to clinical research in another patient population with high unmet need.”
Since July 2021, KERENDIA has been approved to reduce the risk of CV death, hospitalization for heart failure, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with CKD associated with T2D. In July 2025, KERENDIA also received U.S. Food and Drug Administration (FDA) approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) of ≥40%.4
Data from Bayer at ASN Kidney Week 2025 include:
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Finerenone in CKD and Type 1 Diabetes (TH-OR082)
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Opening Plenary: ASN President’s Address, State-of-the-Art Lecture, Featured High-Impact Clinical Trials
- November 6, 2025, 08:00 AM CST – 09:30 AM CST, Hall A, Convention Center
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Opening Plenary: ASN President’s Address, State-of-the-Art Lecture, Featured High-Impact Clinical Trials
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Joint Effects of Urine Albumin-to-Creatinine Ratio (UACR) and eGFR on Efficacy and Safety with Simultaneous Initiation of Finerenone and an SGLT2 Inhibitor in the CONFIDENCE Trial (TH-PO1204)
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Late-Breaking Research Posters
- November 6, 2025, 10:00 AM CST – 12:00 PM CST, Exhibit Hall, Convention Center
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Late-Breaking Research Posters
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Serum Potassium, Hyperkalemia, and the Effect of Hyperkalemia on Treatment Efficacy with Empagliflozin, Finerenone, or Both: A CONFIDENCE Trial Report (OR090)
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Late-Breaking Research Orals – 2
- November 7, 2025, 04:54 PM CST – 05:06 PM CST, Grand Ballroom C, Convention Center
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Late-Breaking Research Orals – 2
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Dosing, Treatment Patterns, Urine Albumin-to-Creatinine Ratio (UACR) Changes, and Safety with Finerenone Treatment in Routine Care: FINE-REAL Interim Analysis (TH-OR080)
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Precision Medicine in Diabetic Kidney Disease: Biomarkers, Combination Therapies, and Treatment Response Prediction
- November 6, 2025, 05:40 PM CST – 05:50 PM CST, Room 372A, Convention Center
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Precision Medicine in Diabetic Kidney Disease: Biomarkers, Combination Therapies, and Treatment Response Prediction
About KERENDIA® (finerenone)4
INDICATION:
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:
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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.
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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%).5 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 full Prescribing Information for KERENDIA.
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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros.
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 Rossing P, Per-Henrik Groop, Singh R, Lawatscheck R, Tuttle KR. Prevalence of Chronic Kidney Disease in Type 1 Diabetes Among Adults in the U.S. Diabetes Care. Published online June 10, 2024. doi:https://doi.org/10.2337/dc24-0335
2 Tuttle KR, Reynolds CL, Kornowske LM, et al. Prevalence and severity of chronic kidney disease in a population with type 1 diabetes from a United States health system: a real-world cohort study. The Lancet Regional Health – Americas. 2025;47:101130. doi:https://doi.org/10.1016/j.lana.2025.101130
3 Hiddo J.L. Heerspink, Birkenfeld AL, David Z.I. Cherney, et al. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Diabetes Research and Clinical Practice. 2023;204:110908-110908. doi:https://doi.org/10.1016/j.diabres.2023.110908
4 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 October 1, 2025.
5 Data on file.
Contacts
Media Contact:
Sarra Herzog
Bayer Media Relations
Sarra.Herzog@bayer.com
862.460.8764