Kidney Week

Abstract: TH-PO1239

Effects of Finerenone on Kidney and Cardiovascular Outcomes in Patients with CKD and Type 1 Diabetes: An Analysis from FINE-ONE and FIDELITY

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Heerspink, Hiddo Jan L., Rijksuniversiteit Groningen, Groningen, Netherlands

Hiddo Jan L. Heerspink, PharmD, PhD

• Birkenfeld, Andreas L., University Hospital and Faculty of Medicine, Tübingen, Germany

Andreas L. Birkenfeld, MD

• Cherney, David, University of Toronto, Toronto, Ontario, Canada

David Cherney, MD, PhD

• Colhoun, Helen, University of Edinburgh, Edinburgh, United Kingdom

Helen Colhoun, MD, MBChB

• Groop, Per-Henrik, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

Per-Henrik Groop, MD, PhD

• Ji, Linong, Peking University, Beijing, China

Linong Ji, MD

• McGill, Janet B., Washington University in St Louis School of Medicine, St. Louis, Missouri, United States

Janet B. McGill, MD, MA

• Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark

Peter Rossing, MD, DrMed

• Rosas, Sylvia E., Joslin Diabetes Center and Harvard Medical School, Boston, Massachusetts, United States

Sylvia E. Rosas, MD, MS, FASN

• Kwak, Soo Heon, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of)

Soo Heon Kwak, MD, PhD

• Solis-Herrera, Carolina, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Carolina Solis-Herrera, MD

• Farjat, Alfredo E., Bayer B.V., Hoofddorp, Netherlands

Alfredo E. Farjat, PhD

• Lawatscheck, Robert, Bayer, Berlin, Germany

Robert Lawatscheck, MD

• Russell, Julie, Bayer, Reading, United Kingdom

Julie Russell, MSc

• Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States

Richard E. Pratley, MD

Background

Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduced urinary albumin-to-creatinine ratio (UACR), a bridging biomarker for CKD progression, in people with CKD and T1D in the FINE-ONE trial, although long-term clinical outcomes were not investigated. This propensity score (PS) analysis matched FINE-ONE participants (pts) to pts with CKD and T2D in the FIDELITY pooled analysis. Long-term clinical outcomes with finerenone for pts with T1D and CKD were estimated based on outcomes in FINE-ONE–like pts from FIDELITY.

Methods

Pts in FINE-ONE and FIDELITY on optimized renin–angiotensin system inhibition, randomized 1:1 to finerenone or placebo (PBO), were matched 1:8 via PS based on baseline characteristics. Outcomes were UACR change, eGFR decline over time, a kidney composite (kidney failure, sustained ≥57% eGFR decrease from baseline or kidney-related death), hospitalization for heart failure (HHF), and treatment-emergent hyperkalemia.

Results

Baseline characteristics were similar between matched pts, except age, insulin use and diabetes duration (16 years longer in FINE-ONE [n=240] vs FIDELITY [n=1,897]). In the FIDELITY-matched population, finerenone reduced UACR by 31% at Month 4 (p<0.001) and total eGFR slope by 0.6 mL/min/1.73 m²/year vs PBO (95% confidence interval [CI] 0.1–1.0; Fig 1A). Finerenone reduced composite kidney outcome risk by 45% (95% CI 16–64%) and HHF risk by 36% (95% CI 2–58%) vs PBO (Fig 1B). Hyperkalemia was more frequent with finerenone (16.5%) vs PBO (7.8%), with related discontinuation (1.7% vs 0.8%) and hospitalization rates (1.1% vs 0.3%) being low.

Conclusion

These data suggest that UACR reduction with finerenone is likely to lead to long-term kidney and CV benefits in pts with T1D and CKD, as seen in matched T2D and CKD pts.

Funding

• Commercial Support – Bayer AG