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KERENDIA® (finerenone) Meets Primary Endpoint in Phase III Clinical Trial for Adults with Type 1 Diabetes and Chronic Kidney Disease

WHIPPANY, N.J., November 06, 2025--Bayer today announced new Phase III investigational data from the pivotal FINE-ONE trial showing that KERENDIA® (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87]; p=0.0001).1 These late-breaking data were presented today at the opening plenary sess

articleBayer AgNovember 6, 202514/company/bayer-ag-na/news/kerendiar-finerenone-meets-primary-endpoint-in-phase-iii-clinical-trial-for-adults-with-type-1-diabetes-and-chronic-kidney-disease
KERENDIA® (finerenone) Meets Primary Endpoint in Phase III Clinical Trial for Adults with Type 1 Diabetes and Chronic Kidney Disease

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[{"type":"list","items":[{"val":[{"type":"text","content":"The investigational FINE-ONE trial met its primary endpoint, demonstrating that finerenone led to a significant reduction in urine albumin-to-creatinine ratio (UACR), an important marker of cardiovascular risk and kidney disease progression, from start of trial through six months, for people living with type 1 diabetes (T1D) and chronic kidney disease (CKD) versus those receiving standard of care plus placebo1","length":413,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"These data were presented as a late-breaker at the opening plenary session at the American Society of Nephrology (ASN) Kidney Week 2025","length":135,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Additionally, three presentations from the CONFIDENCE trial in patients with type 2 diabetes (T2D) and CKD, which investigated simultaneous administration of finerenone and a sodium-glucose transport protein 2 inhibitor (SGLT2i),2 will also be presented as two late-breaking analyses and featured independently as part of the "Best of the Journal of the American Medical Association and the New England Journal of Medicine" session","length":441,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":989,"olType":false},{"type":"text","content":"WHIPPANY, N.J., November 06, 2025--(BUSINESS WIRE)--Bayer today announced new Phase III investigational data from the pivotal FINE-ONE trial showing that KERENDIA® (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87]; p=0.0001).1 These late-breaking data were presented today at the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 in Houston by Dr. Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Chair of the study’s Steering Committee.","length":781,"tagName":"p"},{"type":"text","content":""We are excited to announce the results of the FINE-ONE trial, which represents the first positive Phase III study in 30 years dedicated to patients with type 1 diabetes and chronic kidney disease3—a research adva...

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chronic kidney diseasekidney diseasecardiovascular risktype 1 diabetesAmerican Society of Nephrologyfinerenoneheart failureClinical TrialsKERENDIAClinical trial registrationPhase III studytype 2 diabetes