Kidney Week

Abstract: FR-PO322

Dosing, Treatment Pattern, and Safety of Finerenone Use in Routine Care: An Interim Analysis of the Prospective, Real-World, and Observational FINE-REAL Study

Session Information

• Diabetic Kidney Disease: Clinical Modeling, Diagnosis, Education, and More
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Wanner, Christoph, Hospital Würzburg, Würzburg, Germany

Christoph Wanner, MD

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

David C. Wheeler, MD

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

Kevin M. Pantalone, DO

• Guo, Lixin, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China

Lixin Guo, PhD

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

Nihar Desai, MD, MPH

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

Ricardo Correa-Rotter, MD

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

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

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

Susanne B. Nicholas, MD, PhD, MPH

• Fatoba, Samuel T., Bayer US LLC, Whippany, New Jersey, United States

Samuel T. Fatoba, PhD, MPH

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

Andrea Horvat-Broecker

• Merz, Martin, Bayer AG, Berlin, Germany

Martin Merz

Background

FINE-REAL (NCT05348733) is evaluating the use of finerenone in patients (pts) with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in routine clinical practice. This interim analysis describes the dosing, treatment pattern, and safety of finerenone.

Methods

Global, prospective, single-arm, non-interventional study of pts aged ≥18 years with CKD and T2D treated with finerenone.

Results

Of the 1826 pts in this analysis, 1179 (65%) were male and 1682 (92%) were aged ≥50 years. Median follow-up time (IQR) was 269 (150–363) days. At baseline, UACR was available for 1081 (59%) pts, with a median (IQR) UACR of 300 (89–809) mg/g. Mean (SD) eGFR was 54 (24) mL/min/1.73 m² (n=1331). At baseline, ACEi/ARBs, SGLT2i, or GLP-1 RA were used by 1298 (71%), 946 (52%), and 522 (29%) pts, respectively. At initiation, 1475 (81%) pts received 10 mg finerenone and 349 (19%) pts received 20 mg finerenone. At 12 months, 372 (25%) pts starting with 10 mg were up-titrated at least once, while 27 (8%) pts starting with 20 mg were down-titrated at least once. At 12 months, 70% of pts with no UACR available (n=253) received 10 mg finerenone; 29% received 20 mg. Of those with UACR available at 12 months, pts with UACR <30 mg/g (n=22) were less likely to receive 20 mg vs 10 mg finerenone (18% vs 82%) than those with UACR 30−300 mg/g (n=83; 37% vs 62%) or >300 mg/g (n=121; 41% vs 59%). Hyperkalemia events were observed in 140 (8%) pts. Treatment-emergent adverse events (AEs) and serious AEs were observed in 574 (31%) and 153 (8%) pts, respectively.

Conclusion

By UACR, the FINE-REAL study population has milder renal impairment than in other pivotal analyses such as FIDELIO DKD. Comedication of finerenone with ACEi/ARBs, SGLT2i, or GLP-1 RA is more optimized in the FINE-REAL study population than is typically observed in real-world practice. Pts with higher UACR received higher finerenone doses, and pts with no UACR available at baseline received lower doses. Safety was consistent with the known safety profile of the drug.

Funding

• Commercial Support – Bayer AG