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Kidney Week

Abstract: FR-PO0496

Finerenone in Patients with CKD and Type 1 Diabetes According to Geographic Region: A FINE-ONE Analysis

Session Information

Category: Cardiovascular-Kidney-Metabolic Health

  • 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

  • Ji, Linong, Departments of Endocrinology and Metabolism, Peking University People's Hospital, Peking University Diabetes Center, Beijing, China
  • Birkenfeld, Andreas L., Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany
  • Cherney, David, Division of Nephrology, University Health Network, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada
  • Colhoun, Helen, Institute of Genetics and Cancer, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, United Kingdom
  • Groop, Per-Henrik, Department of Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
  • Mathieu, Chantal, Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium
  • McGill, Janet B., Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine in St. Louis, St Louis, Missouri, United States
  • Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States
  • Rosas, Sylvia E., Kidney and Hypertension Unit, Joslin Diabetes Center and Harvard Medical School, Boston, Massachusetts, United States
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Tuttle, Katherine R., Providence Inland Northwest Health, University of Washington School of Medicine, Spokane, Washington, United States
  • Amor, Antonio J., Diabetes Unit, Endocrinology and Nutrition Department, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
  • Bech, Jesper N., Region Midtjylland, Regionshospitalet Godstrup - Nephrology Department, Herning, Denmark
  • Caramori, M. Luiza A., Department of Endocrinology and Metabolism, Cleveland Clinic Foundation, Cleveland, Ohio, United States
  • Fiorina, Paolo, ASST Fatebenefratelli Sacco Ospedale Sacco - Malattie Endocrine e Diabetologia, Milan, Italy
  • Pagotto, Uberto, Azienda Ospedaliero-Universitaria Di Bologna IRCCS Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete, Bologna, Italy
  • Power, Albert, North Bristol NHS Trust - Southmead Hospital, Bristol, United Kingdom
  • Schousboe, Karoline, Odense University Hospital, Odense - Endocrinology Department, Odense, Denmark
  • Selby, Nicholas M., University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital, Derby, United Kingdom
  • Setola, Emanuela, IRCCS San Raffaele Hospital Scientific Institute, Diabetologia Department - Cardio-Metabolic and Clinical Trials Unit, Milan, Italy
  • Kwak, Soo Heon, Department of Internal Medicine, Seoul National University College of Medicine & Seoul National University Hospital, Seoul, Korea (the Republic of)
  • Lawatscheck, Robert, Cardiology and Nephrology Clinical Development, Bayer, Berlin, Germany
  • Russell, Julie, Bayer, Reading, United Kingdom
  • Heerspink, Hiddo Jan L., George Institute for Global Health, University of New South Wales, Sydney, Australia
Background

Type 1 diabetes (T1D) varies in prevalence and clinical characteristics across geographic regions. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduced albumin-creatinine ratio (UACR) in people with chronic kidney disease (CKD) and T1D in the FINE-ONE trial. This sub-analysis evaluated the effect of finerenone according to geographic region.

Methods

Patients with CKD (UACR 200–<5000 mg/g; estimated glomerular filtration rate [eGFR] 25–<90 mL/min/1.73 m2), T1D, HbA1c <10%, serum potassium ≤4.8 mmol/L, and on a stable dose of renin–angiotensin system blockade were randomized 1:1 to finerenone (10 or 20 mg) or placebo. Relative change in UACR from baseline over 6 months and treatment-emergent adverse events were analyzed among participants in Asia, Europe, and North America.

Results

Of 242 patients, 34% were located in North America, 16% in Asia and 50% in Europe. Median UACR (mg/g) at baseline in the overall population was 549; values per region were 511, 484, and 559 in North America, Asia and Europe, respectively. Over 6 months, UACR reduction with finerenone vs placebo was 18% in North America, 12% in Asia, and 26% in Europe (pinteraction 0.6068) (Figure). Safety was generally balanced between treatment arms with no notable differences across regions and consistent with the overall population. Only 2 patients had a serious hyperkalemic event with finerenone (1 in North America and 1 in Europe).

Conclusion

In patients with CKD and T1D, finerenone reduced UACR vs placebo over 6 months of treatment, irrespective of geographical region, with a consistent overall tolerable safety profile.

Funding

  • Commercial Support – Bayer AG