Imagine a breakthrough that could change the lives of millions battling type 1 diabetes and chronic kidney disease—offering real hope where options have been painfully limited. That's the promise shining through the latest findings on finerenone, a medication that's already making waves in heart and kidney care. But here's where it gets exciting: could this drug finally bridge the gap for those with type 1 diabetes, a group often overlooked in treatment advancements? Let's dive in and explore what the FINE-ONE study reveals, breaking down the science in a way that's easy to follow, even if you're new to all this.
The FINE-ONE trial demonstrates that finerenone delivers a notable benefit by significantly lowering the urine albumin-to-creatinine ratio (UACR) in individuals with type 1 diabetes who also have chronic kidney disease (CKD). For beginners, think of UACR as a key biomarker—a measurable indicator in urine that shows how well the kidneys are filtering protein. High levels often signal kidney damage, and reducing it can slow down the progression of CKD. In simple terms, CKD is a long-term condition where the kidneys don't work as efficiently as they should, leading to waste buildup in the blood, and it's especially tricky for those with type 1 diabetes, where blood sugar management adds another layer of complexity. This study brings fresh optimism for managing these intertwined health challenges.
According to the results shared at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas (from November 5-9, 2025), participants treated with finerenone saw a statistically significant 25% relative drop in UACR compared to those on placebo over a six-month period. The study focused on adults with type 1 diabetes—where the body can't produce insulin—and CKD. You can find more on type 1 diabetes at hcplive.com/clinical/type-1-diabetes and on CKD at hcplive.com/clinical/chronic-kidney-disease, while details on the conference are available at hcplive.com/conference/asn. These outcomes, emerging just under four months after finerenone's approval by the US Food and Drug Administration (FDA) for heart failure with preserved ejection fraction (HFpEF)—a condition where the heart's pumping isn't as strong as it could be—underscore the potential of Bayer's nonsteroidal mineralocorticoid receptor agonist (nsMRA) to help more people grappling with kidney issues. It's like giving doctors a versatile tool that targets the hormonal pathways involved in kidney and heart health.
Dr. Hiddo Lambers Heerspink, a professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen in the Netherlands and the study's steering committee chair, emphasized the real-world impact: 'Individuals dealing with type 1 diabetes and chronic kidney disease are at heightened risk for kidney failure and heart problems, which can severely affect their daily lives and longevity. Lowering UACR is strongly linked to fewer kidney and cardiovascular events. The encouraging outcomes from FINE-ONE mark a pivotal advancement, providing optimism for those with CKD linked to type 1 diabetes, who have had few choices until now.' And this is the part most people miss—the ripple effect of such reductions could mean fewer hospital visits and a better quality of life, potentially extending years of healthier living.
Finerenone has been building its reputation in cardiometabolic health over the past decade. It started with success in type 2 diabetes (where the body resists insulin) and CKD, backed by the FIGARGO-DKD and FIDELIO-DKD trials that led to FDA approval in 2021 for CKD associated with type 2 diabetes. Then came the FINEARTS-HF trial, paving the way for its July 2025 nod for HFpEF. Now, FINE-ONE adds evidence of its value in CKD for type 1 diabetes patients. It's a story of progressive expansion, showing how one medication can adapt to different needs.
Designed as a randomized, double-blind, placebo-controlled, multicenter trial, FINE-ONE involved 242 volunteers from over 80 locations in nine countries. They were evenly split to take either finerenone (10 mg or 20 mg daily) or a placebo, alongside their usual CKD and related condition treatments. Dosing depended on estimated glomerular filtration rate (eGFR), which is a calculation measuring kidney function based on how well they filter waste:
- 10 mg once daily for those with eGFR between 25 and less than 60 mL/min/1.73 m² (indicating moderate kidney impairment).
- 20 mg once daily for those with eGFR at 60 mL/min/1.73 m² or higher (showing better function).
After 30 days, doses could increase to 20 mg if potassium levels stayed at or below 4.8 mmol/L and eGFR hadn't dropped more than 30% since the last check. This careful approach minimizes risks like high potassium, which can be dangerous.
The main goal was the relative change in UACR from the start, measured over six months. Finerenone hit the mark with a 25% reduction versus placebo (using least squares geometric mean ratio of 0.75; 95% confidence interval 0.65–0.87; p-value 0.0001). To put this in perspective, imagine comparing two groups: one seeing a meaningful dip in this kidney stress marker, the other not. It's statistically solid evidence.
Beyond the primary result, the study showed that at any point after starting, 68.1% (81 out of 119) in the finerenone group hit at least a 30% UACR drop, compared to 46.6% (54 out of 116) in the placebo group. Bayer's announcement pointed out that this 30% threshold matches guidance from the American Diabetes Association, which sees it as a sign of slower diabetic kidney disease progression. In other words, it's not just a number—it's a predictor of better outcomes, like delaying the need for dialysis.
Secondary focuses included adverse events and hyperkalemia (high potassium levels), a key concern. The safety data aligned with past studies on finerenone, including those in type 2 diabetes-related CKD, with no unexpected issues popping up. Checks for potassium, eGFR, and blood pressure happened at every visit, and UACR was monitored at screening, baseline, three months, six months, and one month after treatment ended.
Jonathan Rosen, PhD, research director at Breakthrough T1D, added his voice: 'Those with type 1 diabetes and CKD carry a heavy load from elevated chances of kidney and heart events. Breakthrough T1D is dedicated to partnering with Bayer to enhance kidney care for type 1 diabetes patients.' It's a call to action for more collaboration in this field.
But here's where it gets controversial: While nsMRAs like finerenone have shown promise, some experts debate whether the benefits outweigh the costs or monitoring needs, especially in broader populations. Could the focus on extending it to type 1 diabetes overshadow newer therapies? And is the emphasis on UACR reduction enough, or should we prioritize harder endpoints like preventing dialysis? These questions spark debate—what do you think? Does this expansion feel like a game-changer, or are we rushing ahead without enough long-term data? Share your thoughts in the comments below; I'd love to hear agreements, disagreements, or fresh perspectives to fuel the conversation.
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. 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/
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