Acute eGFR Changes With Finerenone Examined in a Prespecified Analysis of FINE-ONE.
21 affiliations
- 1Division of Nephrology, University Health Network, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
- 2The George Institute for Global Health, University of New South Wales, Sydney, Australia.
- 3Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
- 4Department of Endocrinology and Metabolism, Peking University People's Hospital, Peking University Diabetes Center, Beijing, China.
- 5Division of Endocrinology, Metabolism & Lipid Research, Washington University in St. Louis, School of Medicine, St. Louis, Missouri, USA.
- 6Steno Diabetes Center Copenhagen, Herlev, Denmark.
- 7Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
- 8Providence Medical Research Center, Providence Inland Northwest Health, Spokane, Washington, USA.
- 9Nephrology Division and Kidney Research Institute, University of Washington School of Medicine, Seattle, Washington, USA.
- 10Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
- 11University Clinic in Nephrology and Hypertension, Gødstrup Hospital, Herning, Denmark.
- 12Division of Endocrinology, ASST Fatebenefratelli-Sacco, Milan and Università degli Studi di Milano, Milan, Italy.
- 13Population Health Sciences, Bristol Medical School, University of Bristol, and Renal Unit, North Bristol NHS Trust, Bristol, UK.
- 14Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark.
- 15Centre for Kidney Research and Innovation, Academic Unit for Translational Medical Sciences, Royal Derby Hospital Campus, University of Nottingham, Derby, UK.
- 16Cardio-metabolic and Clinical Trials Unit, IRCCS Ospedale San Raffaele, Milan, Italy.
- 17Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.
- 18Cardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany.
- 19Bayer PLC, Reading, UK.
- 20Clinical Statistics and Analytics, Bayer AG, Berlin, Germany.
- 21Department of Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Abstract
Introduction
The nonsteroidal mineralocorticoid receptor antagonist finerenone reduces urine albumin-to-creatinine ratio (UACR) in people with type 1 diabetes (T1D) and chronic kidney disease (CKD). This prespecified analysis evaluated acute changes in estimated glomerular filtration rate (eGFR) with finerenone and their impact on safety.Methods
Adults with T1D and CKD (n = 242; eGFR ≥ 25-< 90 ml/min per 1.73 m²; UACR ≥ 200 to < 5000 mg/g) receiving stable renin-angiotensin system (RAS) inhibition were randomized 1:1 to finerenone or placebo. The primary outcome was acute change in eGFR (from baseline to month 1), termed "eGFR dip." Reversibility of eGFR change was assessed from end of the treatment (month 6) to follow-up (month 7). Change in eGFR was assessed across eGFR dip subgroups (eGFR > 0 to ≤ 10% decline, > 10% decline, and ≥ 0% increase) and prespecified characteristics (baseline eGFR, UACR, history of cardiovascular disease [CVD], and diuretic use).Results
Mean acute eGFR decline at month 1 was greater with finerenone (-2.78 ml/min per 1.73 m² [95% confidence interval [CI], -4.15 to -1.40]) versus placebo (-0.78 ml/min per 1.73 m²; [95% CI, -2.22 to 0.66]); treatment difference was -1.99 ml/min per 1.73 m² (95% CI, -3.97 to -0.01 [P = 0.049]). Placebo-corrected eGFR increased during the washout period across the groups. Acute eGFR changes did not differ according to prespecified characteristics. The incidence of treatment-emergent adverse events (TEAEs) was comparable across eGFR dip subgroups in both the treatment groups. Greater declines in eGFR were associated with greater reductions in UACR at month 3.Conclusion
In people with T1D and CKD, finerenone induced an acute eGFR dip that was well tolerated without unexpected safety signals.
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BibTeX
@article{cherney2026acute,
title = {{Acute eGFR Changes With Finerenone Examined in a Prespecified Analysis of FINE-ONE.}},
author = {David Z I Cherney and Tae Won Yi and Hiddo J L Heerspink and Linong Ji and Janet B McGill and Peter Rossing and Katherine R Tuttle and Jesper N Bech and Paolo Fiorina and Albert Power and Karoline Schousboe and Nicholas M Selby and Emanuela Setola and J David Smeijer and Robert Lawatscheck and Meike Brinker and Julie Russell and Patrick Schloemer and Per-Henrik Groop and FINE-ONE Investigators23},
journal = {Kidney international reports},
year = {2026},
month = sep,
doi = {10.1016/j.ekir.2026.107083},
url = {https://europepmc.org/article/MED/42927222},
note = {CC BY},
}
RIS
TY - JOUR
TI - Acute eGFR Changes With Finerenone Examined in a Prespecified Analysis of FINE-ONE.
AU - David Z I Cherney
AU - Tae Won Yi
AU - Hiddo J L Heerspink
AU - Linong Ji
AU - Janet B McGill
AU - Peter Rossing
AU - Katherine R Tuttle
AU - Jesper N Bech
AU - Paolo Fiorina
AU - Albert Power
AU - Karoline Schousboe
AU - Nicholas M Selby
AU - Emanuela Setola
AU - J David Smeijer
AU - Robert Lawatscheck
AU - Meike Brinker
AU - Julie Russell
AU - Patrick Schloemer
AU - Per-Henrik Groop
AU - FINE-ONE Investigators23
PY - 2026
DA - 2026/09/16
JO - Kidney international reports
DO - 10.1016/j.ekir.2026.107083
UR - https://europepmc.org/article/MED/42927222
AB - Introduction The nonsteroidal mineralocorticoid receptor antagonist finerenone reduces urine albumin-to-creatinine ratio (UACR) in people with type 1 diabetes (T1D) and chronic kidney disease (CKD). This prespecified analysis evaluated acute changes in estimated glomerular filtration rate (eGFR) with finerenone and their impact on safety.Methods Adults with T1D and CKD (n = 242; eGFR ≥ 25-< 90 ml/min per 1.73 m²; UACR ≥ 200 to < 5000 mg/g) receiving stable renin-angiotensin system (RAS) inhibition were randomized 1:1 to finerenone or placebo. The primary outcome was acute change in eGFR (from baseline to month 1), termed "eGFR dip." Reversibility of eGFR change was assessed from end of the treatment (month 6) to follow-up (month 7). Change in eGFR was assessed across eGFR dip subgroups (eGFR > 0 to ≤ 10% decline, > 10% decline, and ≥ 0% increase) and prespecified characteristics (baseline eGFR, UACR, history of cardiovascular disease [CVD], and diuretic use).Results Mean acute eGFR decline at month 1 was greater with finerenone (-2.78 ml/min per 1.73 m² [95% confidence interval [CI], -4.15 to -1.40]) versus placebo (-0.78 ml/min per 1.73 m²; [95% CI, -2.22 to 0.66]); treatment difference was -1.99 ml/min per 1.73 m² (95% CI, -3.97 to -0.01 [P = 0.049]). Placebo-corrected eGFR increased during the washout period across the groups. Acute eGFR changes did not differ according to prespecified characteristics. The incidence of treatment-emergent adverse events (TEAEs) was comparable across eGFR dip subgroups in both the treatment groups. Greater declines in eGFR were associated with greater reductions in UACR at month 3.Conclusion In people with T1D and CKD, finerenone induced an acute eGFR dip that was well tolerated without unexpected safety signals.
SN - 2468-0249
ER -