FINE-ONE: Finerenone Proves Benefit in Type 1 Diabetes and CKD

Use of finerenone was associated with a statistically significant 25% relative reduction in urine albumin-to-creatinine ratio compared with placebo over 6 months in patients with type 1 diabetes and chronic kidney disease, according to FINE-ONE results from the American Society of Nephrology (ASN) Kidney Week 2025.

The new data, which come less than 4 months after the agent received approval for heart failure with preserved ejection fraction from the US Food and Drug Administration (FDA), offer evidence supporting the use of Bayer’s nonsteroidal mineralocorticoid receptor agonist (nsMRA) in additional populations with kidney disease.1,2

“Patients living with type 1 diabetes and chronic kidney disease face an increased risk of kidney failure and cardiovascular disease, impacting quality of life and life expectancy,” said Hiddo Lambers Heerspink, professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and chair of the study’s Steering Committee.2 “UACR reduction is highly correlated with a reduction in kidney and cardiovascular events. The positive results of the FINE-ONE study represent a landmark moment and give hope to patients with chronic kidney disease associated with type 1 diabetes who currently have very limited treatment options.”

Over the last decade, finerenone has established a significant role in the landscape of cardiometabolic health. First, in people with type 2 diabetes and chronic kidney disease based on the FIGARO-DKD and FIDELIO-DKD trials, which were used in support of the agent’s 2021 approval from the FDA for chronic kidney disease associated with type 2 diabetes. Next, the FINEARTS-HF trial set the stage for the agent’s July 2025 approval for HFpEF.2

Now, FINE-ONE offers evidence of finerenone’s benefit in chronic kidney disease in people with type 1 diabetes.

FINE-ONE was a randomized, double-blind, placebo-controlled, multicenter trial and enrolled 242 participants across more than 80 sites in 9 countries. Participants were randomly assigned in a 1:1 ratio to receive finerenone (10 mg or 20 mg once daily) or placebo, in addition to standard-of-care therapies for chronic kidney disease and comorbidities.1,2

The starting dose of finerenone was based on estimated glomerular filtration rate (eGFR):

• 10 mg once daily for participants with eGFR ≥25 - <60 mL/min/1.73 m²
• 20 mg once daily for participants with eGFR ≥60 mL/min/1.73 m²

After 30 days, uptitration to the 20 mg target dose was permitted if serum/plasma potassium was ≤4.8 mmol/L and eGFR decline was <30% compared with the prior visit.1,2

The primary endpoint was the relative change in UACR from baseline over 6 months. Finerenone treatment achieved a 25% relative reduction in UACR compared with placebo (least squares geometric mean [LSGM] ratio 0.75; 95% CI, 0.65–0.87; P = .0001).1,2

Results also suggested, at any time post-baseline, 68.1% (81/119) of participants in the finerenone arm achieved at least a 30% reduction in UACR, compared with 46.6% (54/116) of participants in the placebo arm. In their press release announcing results, Bayer highlighted this threshold aligns with American Diabetes Association guidance identifying ≥30% UACR reduction as a marker associated with slower progression in diabetic kidney disease.1,2

Secondary endpoints included the number of participants with treatment-emergent adverse events and the incidence of hyperkalemia, designated as an adverse event of special interest. Bayer’s release noted finerenone’s safety profile in FINE-ONE was consistent with previous studies, including those conducted in type 2 diabetes–associated chronic kidney disease, and no new safety signals were identified.1,2

Safety assessments, including serum potassium, eGFR, and blood pressure, were performed at all scheduled visits. UACR was assessed at screening, baseline, month 3, month 6, and at a follow-up visit 1 month post-treatment.1,2

"People with type 1 diabetes and chronic kidney disease face an immense burden due to their increased risk for both kidney and cardiovascular events," said Jonathan Rosen, PhD, research director at Breakthrough T1D.2 "Breakthrough T1D remains committed to collaborating with Bayer to improve kidney care for people with type 1 diabetes."

References:

1. Heerspink HL. Finerenone in CKD and Type 1 Diabetes. Presented at the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.

2. Bayer. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes . Published November 6, 2025. Accessed November 6, 2025. https://www.bayer.com/media/en-us/finerenone-showed-statistically-significant-reduction-of-uacr-in-adults-with-chronic-kidney-disease-associated-with-type-1-diabetes/