Clinicians have long sought effective treatments for kidney disease in patients with autoimmune diabetes. Recently, the phase 3 FINE-ONE trial explored Finerenone in Type 1 Diabetes to address this unmet medical need. This nonsteroidal mineralocorticoid receptor antagonist already shows success in type 2 diabetes. However, its effectiveness in type 1 diabetes was previously unknown. New data now suggest that this drug significantly protects kidney function by reducing albuminuria.
Benefits of Finerenone in Type 1 Diabetes
The primary finding of the FINE-ONE trial centers on the urine albumin-to-creatinine ratio (UACR). Specifically, patients receiving finerenone experienced a 25% reduction in UACR compared to the placebo group. Because UACR serves as a critical biomarker for kidney disease progression, this result is highly promising. Furthermore, nearly 68% of participants achieved a reduction of 30% or more. This threshold often correlates with a slower decline in kidney function. Therefore, the drug provides a potential breakthrough for a population that has lacked new therapies for three decades. Additionally, the benefits remained consistent across various patient subgroups. Consequently, doctors might soon have a potent tool to manage chronic kidney disease in type 1 diabetes patients more effectively.
Safety Results from the FINE-ONE Trial
Safety remains a paramount concern when introducing new therapies for chronic conditions. In the FINE-ONE trial, researchers found that finerenone was generally safe for participants. For instance, the rate of serious adverse events was similar between the drug and placebo groups. Although hyperkalemia occurred more frequently with finerenone at 10.1%, the clinical impact remained minimal. Only 1.7% of patients had to stop treatment because of high potassium levels. Moreover, the mean increase in serum potassium was only 0.14 mmol/L. Thus, the safety profile appears consistent with findings in type 2 diabetes populations. While clinicians must monitor potassium levels, the risk-benefit ratio looks very favorable for most patients. In conclusion, these results provide strong evidence for the registration of finerenone as a standard therapy for this high-risk group.
Frequently Asked Questions
Q1: How does finerenone help people with type 1 diabetes?
Finerenone blocks mineralocorticoid receptor overactivation, which reduces inflammation and scarring in the kidneys. In the FINE-ONE trial, it lowered urine albumin levels by 25%, indicating significantly reduced kidney damage.
Q2: What are the main side effects of this medication?
The most common side effect is hyperkalemia, or elevated blood potassium levels. However, clinical trials show that very few patients need to stop the medication due to this issue, and it is generally manageable with monitoring.
References
- Heerspink HJL et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med. 2026 Mar 05. doi: 10.1056/NEJMoa2512854. PMID: 41780000.
- Bayer. KERENDIA® (finerenone) Meets Primary Endpoint in Phase III Clinical Trial for Adults with Type 1 Diabetes and Chronic Kidney Disease. Published November 06, 2025.
- Heerspink HJL. FINE-ONE: Finerenone Proves Benefit in Type 1 Diabetes and CKD. Presented at ASN Kidney Week; November 06, 2025; Houston, TX.