Finerenone improves albuminuria in adults with type 1 diabetes and chronic kidney disease

1. In this phase 3 trial involving patients with type 1 diabetes and chronic kidney disease, finerenone was associated with significantly greater decreases in urinary albumin-to-creatinine ratio as compared to placebo.

2. Finerenone had an overall favorable safety profile but was associated with higher rates of hyperkalemia than placebo.  

Evidence Rating Level: 1 (Excellent)

Study Rundown: Numerous therapies such as sodium-glucose cotransporter 2 (SGLT2) inhibitors, mineralocorticoid receptor antagonists, and glucagon-like peptide-1 (GLP-1) receptor agonists have shown efficacy in treating patients with type 2 diabetes and chronic kidney disease (CKD). However, there is a lack of data in patients with type 1 diabetes, which is highly prevalent and presents with similar risk. Finerenone is a nonsteroidal mineralocorticoid receptor antagonist which has been shown to improve outcomes in patients with type 2 diabetes and CKD. This study, the FINE-ONE trial, assessed the safety and efficacy of finerenone in adults with type 1 diabetes and CKD. It was found that those who received finerenone had a one-quarter greater decrease in urinary albumin-to-creatinine ratio compared to those who received placebo. Results were consistent across subgroups, including patients at the highest risk for adverse renal and cardiovascular outcomes. Patients in the finerenone group also had a greater reduction in eGFR than placebo patients. Both decreases in albumin-to-creatinine ratio and in eGFR were noted to trend back toward baseline during the washout period. Regarding safety outcomes, approximately half of patients in both the finerenone and placebo groups experienced an adverse event, with a similar rate of severe adverse events across both groups. Hyperkalemia was reported in three times as many finerenone patients as placebo. This study was limited by a relatively short follow-up period and the use of a surrogate biomarker as the primary outcome. Overall, finerenone therapy resulted in significant improvement to the urinary albumin-to-creatinine ratio versus placebo in adults with type 1 diabetes and CKD.

Click to read the study in NEJM

Relevant Reading: Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis

In-Depth [randomized controlled trial]: This phase 3 randomized-controlled trial assessed the efficacy and safety of finerenone in adults with type 1 diabetes and CKD. Key eligibility criteria included albuminuria for at least 3 months, glycated hemoglobin less than 10, serum potassium level below 4.8 mmol per liter, and receipt of a stable dose of an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker for at least 4 weeks. Those who had received an SGLT2 inhibitor or a GLP-1 receptor agonist within 8 weeks of screening were excluded. A total of 242 participants were randomly assigned in a 1:1 ratio to receive either oral finerenone (10 or 20 mg per day) or placebo. The primary outcome was change in urinary albumin-to-creatinine ratio from baseline over six months. Secondary outcomes included changes in eGFR, blood pressure, and serum potassium level. The urinary albumin-to-creatinine ratio decreased by 25% more with finerenone than with placebo (least-squares geometric mean ratio, 0.75; 95% confidence interval [CI], 0.65 to 0.87; p<0.001). The least-squares mean change in the eGFR over six months of treatment was -5.6 (95% CI, -7.0 to -4.2) with finerenone and -2.7 (95% CI, -4.5 to -1.0) with placebo. There were no significant changes in blood pressure, glycated hemoglobin level, or body weight in either group. In terms of safety, 47.1% of the finerenone group and 49.2% of the placebo group experienced adverse events, with similar rates of serious adverse events occurring in both groups (11.8% versus 11.5%). Hyperkalemia was the most common adverse event, occurring in 10.1% of finerenone patients and 3.3% in placebo patients. In summary, these results demonstrate that finerenone was safe and effective in reducing urinary albumin-to-creatinine ratio in adults with type 1 diabetes and CKD.

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