A New Hope for Those Battling Type 1 Diabetes and Kidney Disease?
For individuals grappling with type 1 diabetes and chronic kidney disease, the challenges can seem overwhelming. The increased risk of kidney failure and cardiovascular issues casts a long shadow, significantly impacting quality of life and life expectancy. But what if there was a new path forward? Recent findings from the FINE-ONE study offer a glimmer of hope, suggesting a significant breakthrough in treatment.
The study's results, presented at the American Society of Nephrology (ASN) Kidney Week 2025, highlight the benefits of finerenone, a nonsteroidal mineralocorticoid receptor agonist (nsMRA) developed by Bayer. The data reveal that finerenone substantially reduces the urine albumin-to-creatinine ratio (UACR) in patients with type 1 diabetes and chronic kidney disease. Specifically, finerenone achieved a 25% relative reduction in UACR compared to a placebo over a six-month period. This is a crucial finding, as UACR reduction is strongly linked to a decrease in kidney and cardiovascular events.
But here's where it gets interesting: the study included 242 participants across 80 sites in 9 countries. Participants were randomly assigned to receive either finerenone (at either 10 mg or 20 mg once daily) or a placebo, in addition to standard treatments. The starting dose was determined by the estimated glomerular filtration rate (eGFR).
- For those with an eGFR between 25 and 60 mL/min/1.73 m², the starting dose was 10 mg.
- For those with an eGFR of 60 mL/min/1.73 m² or higher, the starting dose was 20 mg.
After 30 days, the dose could be increased to 20 mg if potassium levels were at or below 4.8 mmol/L and the eGFR decline was less than 30%. This careful approach ensured patient safety throughout the trial.
And this is the part most people miss: The study also revealed that 68.1% of patients in the finerenone group achieved at least a 30% reduction in UACR, compared to 46.6% in the placebo group. This threshold is noteworthy because it aligns with guidelines from the American Diabetes Association, which identifies a ≥30% UACR reduction as a marker of slower progression in diabetic kidney disease.
Finerenone has already established its role in cardiometabolic health over the last decade. It received approval for chronic kidney disease associated with type 2 diabetes in 2021, based on the FIGARGO-DKD and FIDELIO-DKD trials. Furthermore, the FINEARTS-HF trial paved the way for its approval for heart failure with preserved ejection fraction (HFpEF) in July 2025.
Throughout the FINE-ONE study, safety assessments, including serum potassium, eGFR, and blood pressure, were conducted at all scheduled visits. UACR was assessed at the beginning, at months 3 and 6, and at a follow-up visit one month after treatment concluded. The safety profile of finerenone in FINE-ONE aligned with previous studies, with no new safety concerns identified.
Controversy & Comment Hooks:
Do you think these findings represent a significant advancement in treating type 1 diabetes-related kidney disease? Are there any aspects of the study that raise concerns or questions for you? Share your thoughts in the comments below – let's discuss!