Breakthrough T1D Encouraged by Promising Results of FINE-ONE Phase 3 Clinical Trial Evaluating Finerenone for Chronic Kidney Disease Associated with Type 1 Diabetes

NEW YORK, Nov. 6, 2025 /PRNewswire/ -- Results of the Bayer-led Phase 3 FINE-ONE clinical trial, presented at the American Society of Nephrology Kidney Week in Houston, demonstrate that finerenone significantly reduced the urine albumin-to-creatine ratio (UACR) from baseline over six months in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). A reduction in UACR has been shown to indicate a delay in CKD progression, improved kidney health, and decreased cardiovascular complication risks.

Chronic kidney disease remains a significant risk for those living with T1D, with nearly one in three individuals with T1D developing kidney disease in their lifetime. Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that is approved for treatment of adults with CKD associated with type 2 diabetes. The results of the FINE-ONE trial, which Bayer plans to provide to health authorities for regulatory assessment of finerenone in CKD associated with T1D, are evidence that it is effective for CKD associated with T1D as well.

"We are thrilled to see the results from FINE-ONE showing that finerenone improved kidney health in people with type 1 diabetes and chronic kidney disease," said Jonathan Rosen, Ph.D., Research Director at Breakthrough T1D. "Few kidney therapies are currently available for people with type 1 diabetes, and FINE-ONE is a landmark achievement. Breakthrough T1D applauds Bayer for addressing the huge unmet need by conducting this pivotal phase 3 program and is grateful for the collaboration on this effort."

Breakthrough T1D was a strategic collaborator on the FINE-ONE trial and is committed to further collaboration with Bayer to support therapy development and improved treatment of CKD and other chronic conditions for people with T1D.

About Breakthrough T1D, Formerly JDRF 

As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. 

About Type 1 Diabetes (T1D) 
T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts approximately 9.5 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. 

Contact:
Casey Fielder
509-651-0087
media@breakthroughT1D.org

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SOURCE Breakthrough T1D, Formerly JDRF