1394-P: Impact of Finerenone on Albuminuria in Type 1 Diabetes by Baseline HbA1c Levels and Diabetes Duration: An Exploratory Analysis of the FINE-ONE Trial

Introduction and Objective: The nonsteroidal mineralocorticoid receptor antagonist finerenone has been reported to improve UACR in people with T1D and CKD. This prespecified analysis evaluated whether safety and efficacy of finerenone varied by baseline HbA1c levels and diabetes duration. Methods: In total, 242 adults with T1D, CKD (eGFR ≥25 to 90 mL/min/1.73 m2; UACR ≥200 to 5000 mg/g), and on stable ACEi/ARB therapy were randomized 1:1 to receive finerenone (10 or 20 mg per day) or matching placebo. The primary outcome was the relative change in UACR from baseline over 6 months. Results: Baseline HbA1c (mean ± SD: 7.6 ± 1.1%) was available for 240 (99%) FINE-ONE participants. At 6 months, HbA1c was unchanged in both treatment arms (change from baseline 95% CI: finerenone 0.03% -0.14, 0.20; placebo 0% -0.12, 0.11; between-group difference 0.04% -0.17, 0.24; p=0.74). Participants were stratified by HbA1c tertiles: 1 (HbA1c 7.1%), 2 (HbA1c ≥7.1 to ≤8.1%), and 3 (HbA1c 8.1%). Across the 6-month trial duration, median UACR decreased from 574.6 to 373.5 mg/g with finerenone and from 506.4 to 475.6 mg/g with placebo, corresponding to a 25% (95% CI 35, 13) UACR reduction (p=0.0001). There was no heterogeneity in the treatment effect of finerenone on UACR across HbA1c tertiles 1, 2, and 3 (geometric mean 95% CI: -17% -40, 13, -18% -39, 10, and -37% -55, -13, respectively; p interaction = 0.41). When analyzed by diabetes duration, the reduction in UACR with finerenone vs placebo was also consistent across tertiles (25 years, ≥25 to ≤38 years, and 38 years; p interaction = 0.70). Hyperkalemia was the most common adverse event. Safety was comparable across tertiles of HbA1c and diabetes duration. Conclusion: In adults with T1D and CKD, finerenone reduced UACR compared with placebo irrespective of baseline HbA1c levels or diabetes duration, and it was well tolerated. Disclosure P. Rossing: Advisory Panel; Ended; Abbott Diagnostics. Advisory Panel; Current; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Eli Lilly and Company. Consultant; Current; Lexicon Pharmaceuticals, Inc., Roche Pharmaceuticals. Consultant; Ended; Amgen Inc. H. Heerspink: Consultant; Current; AstraZeneca, Alnylam Pharmaceuticals, Inc., Amgen Inc., Bayer AG, Boehringer Ingelheim International GmbH, Dimerix, Eli Lilly and Company, Novo Nordisk, Novartis AG, Roche Pharmaceuticals. A.J. Amor: Speaker's Bureau; Ended; Lilly. Research Support; Ended; Novo Nordisk. A.L. Birkenfeld: None. L. Caramori: Consultant; Current; Bayer AG. Research Support; Ended; Bayer AG, Eli Lilly and Company. Research Support; Current; Boehringer Ingelheim International GmbH. Consultant; Current; Novo Nordisk. Other - Content reviewer; Current; UpToDate. D. Cherney: Consultant; Current; Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Mitsubishi-Tanabe, Abbvie, Janssen, AMGEN, Bayer, Prometic, BMS, Maze, Gilead, CSL-Behring, Otsuka, Novartis, Youngene, Lexicon, Inversago, GSK,. Research Support; Current; Boehringer Ingelheim-Lilly, Merck, Janssen, Sanofi, AstraZeneca, CSL-Behring, Lexicon, Novo-Nordisk, Bayer. H.M. Colhoun: Research Support; Current; Diabetes UK, IQVIA Inc., Sanofi, JDRF, Chief Scientist Office. Research Support; Ended; Medical Research Council (UKRI). Other - Personal payment for consultancy (ENDED);Research support (ongoing); Current; Sanofi. Other - Advisory board member (ongoing); Support for attendance at meetings /conferences and travel; Current; Novo Nordisk. Other - Advisory panel member (ongoing);Stockholder (up to January 2025- ENDED); Current; Bayer AG. Other - Stockholder (ongoing);Institutional payment for consultancy (ongoing); Current; Roche Pharmaceuticals. P. Henrick Groop: Other - Lecture Fees; Current; Astellas Pharma Inc., AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim, Eli Lilly and Company, Elo Water, Medscape, MSD, Mundipharma, Nestlé, Novartis AG, Novo Nordisk, Sanofi. P. Fiorina: Board Member; Ended; A. Menarini Diagnostics, Novo Nordisk, AstraZeneca, Bristol-Myers Squibb Company. L. Ji: None. N. Jongs: Other - Travel Support; Current; AstraZeneca. C. Mathieu: Advisory Panel; Current; Abbott Diagnostics, Dexcom, Inc. Board Member; Current; European Association for the Study of Diabetes. Advisory Panel; Current; Novo Nordisk, Eli Lilly and Company, Sanofi, Vertex Pharmaceuticals Incorporated, Medtronic. U. Pagotto: Advisory Panel; Ended; Eli Lilly and Company. Speaker's Bureau; Ended; Eli Lilly and Company. Advisory Panel; Ended; Novo Nordisk. Speaker's Bureau; Ended; Novo Nordisk. Advisory Panel; Ended; Boehringer Ingelheim International GmbH. Speaker's Bureau; Ended; Rhythm Pharmaceuticals, Inc. Research Support; Current; Novo Nordisk. S. Rosas: Advisory Panel; Current; Bayer AG. Research Support; Ended; Bayer AG. Advisory Panel; Current; Novo Nordisk. Advisory Panel; Ended; Travere. E. Setola: Speaker's Bureau; Ended; Sanofi, Eli Lilly and Company. Advisory Panel; Ended; Novo Nordisk, Boehringer Ingelheim International GmbH. J. Skyler: Advisory Panel; Ended; AbbVie Inc. Consultant; Current; ADOCIA. Board Member; Current; Applied Therapeutics. Advisory Panel; Current; Avotres Inc., Bayer AG. Consultant; Current; Eli Lilly and Company. Advisory Panel; Current; Kriya Therapeutics. Consultant; Current; Novo Nordisk. Board Member; Current; SAB Biotherapeutics, Inc. Consultant; Current; Sanofi, Vertex Pharmaceuticals Incorporated. K. Tuttle: Consultant; Ended; Alnylam Pharmaceuticals, Inc. Consultant; Current; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, GlaxoSmithKline plc., Novo Nordisk, Lilly, ProKidney. Consultant; Ended; Roche Diabetes Care. Research Support; Ended; Travere. R. Lawatscheck: Employee; Current; Bayer AG. M. Brinker: Employee; Current; Bayer AG. Other - pending patent for finerenone for treatment of patients with CKD and T1D; Current; Bayer AG. Stock/Shareholder; Current; Bayer AG. J. jRussell: Employee; Current; Bayer PLC. P. Schloemerk: Employee; Current; Bayer AG. J.B. McGill: Consultant; Current; Bayer AG. Advisory Panel; Current; MannKind Corporation. Advisory Panel; Ended; Novo Nordisk, Abbott Diagnostics. Consultant; Ended; Pfizer Inc. Research Support; Ended; Lexicon Pharmaceuticals, Inc. Research Support; Current; Novo Nordisk A/S, Lilly, Viking Therapeutics, Diamyd, Cour Pharmaceutical. Funding Funding Bayer. FINE-ONE Trial registration number: NCT05901831