Kidney Week

Abstract: TH-OR080

Dosing, Treatment Patterns, Urine Albumin-to-Creatinine Ratio (UACR) Changes, and Safety with Finerenone Treatment in Routine Care: FINE-REAL Interim Analysis

Session Information

• Precision Medicine in Diabetic Kidney Disease: Biomarkers, Combination Therapies, and Treatment Response Prediction
  November 06, 2025 | Location: Room 372A, Convention Center
  Abstract Time: 05:40 PM - 05:50 PM

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Correa-Rotter, Ricardo, Instituto Nacional de Ciencias Médicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Mexico

Ricardo Correa-Rotter, MD

• Wanner, Christoph, University Hospital Würzburg, Würzburg, Germany

Christoph Wanner, MD

• Wheeler, David C., University College London, London, United Kingdom

David C. Wheeler, MD

• Guo, Lixin, Chinese Academy of Medical Sciences, Bejing, China

Lixin Guo, PhD

• Desai, Nihar, Yale School of Medicine, New Haven, Connecticut, United States

Nihar Desai, MD, MPH

• Navaneethan, Sankar D., Baylor College of Medicine, Houston, Texas, United States

Sankar D. Navaneethan, MD, MS, MPH, FASN

• Nicholas, Susanne B., David Geffen School of Medicine, University of California, Los Angeles, California, United States

Susanne B. Nicholas, MD, PhD, MPH

• Kim, Nan Hee, Korea University College of Medicine, Seongbuk-gu, Seoul, Korea (the Republic of)

Nan Hee Kim, MD

• Mares, Jon, Bayer US LLC, Whippany, New Jersey, United States

Jon Mares

• Ares Gomez, Maria Sonia, Syneos Health, Madrid, Spain

Maria Sonia Ares Gomez, MSc, PhD, DVM

• Horvat-Broecker, Andrea, Bayer AG, Wuppertal, Germany

Andrea Horvat-Broecker

• Schulze, Marcel, Bayer AG, Berlin, Germany

Marcel Schulze, MSc

• Merz, Martin, Bayer AG, Berlin, Germany

Martin Merz

• Pantalone, Kevin M., Cleveland Clinic, Cleveland, Ohio, United States

Kevin M. Pantalone, DO

Background

FINE-REAL (NCT05348733) assesses real-world finerenone use in participants (pts) ≥18 years with chronic kidney disease and type 2 diabetes mellitus. This interim analysis describes dosing strategies, treatment patterns, UACR changes, and safety during treatment with finerenone.

Methods

Global, prospective, single-arm, non-interventional study.

Results

Of 3505 pts, 2309 (66%) were male; mean (SD) age was 67 (11) years. Median (IQR) follow-up was 334 (224–367) days. At baseline, mean (SD) eGFR was 53 (23) mL/min/1.73 m² (n=3388). Concomitant RAASi, SGLT2i, and GLP-1 RA were used by 2837 (81%), 2020 (58%), and 955 (27%) pts, respectively. Finerenone was initiated at 10 mg in 2917 (83%) and 20 mg in 588 (17%) pts. UACR data are shown in the table. Baseline median UACR was low (322 mg/g). Treatment-emergent adverse events (AEs) and serious AEs were observed in 1321 (38%) and 376 (11%) pts, respectively. Treatment-emergent hyperkalemia events were reported in 285 (8%) pts including serious events in 23 (0.7%) pts, leading to hospitalization in 7 (0.2%) and leading to permanent discontinuation in 4 (0.1%); none led to dialysis or death.

Conclusion

By UACR, renal impairment was milder in FINE-REAL versus other major analyses, e.g. FIDELIO-DKD. Use of concomitant RAASi, SGLT2i, or GLP-1 RA was higher in FINE-REAL than in typical real-world practice. Despite intense background therapy, UACR declined between baseline and 4 months with little further change at 12 months. Safety was consistent with the known safety profile of finerenone.

Funding

• Commercial Support – Bayer

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025nz0z1wct