Presenter: Hiddo Lambers Heerspink, PhD, PharmD, University Medical Center Groningen, Netherlands
Finerenone in CKD and type 1 diabetes. Abstract TH-OR082. Presented November 6, 2025.
Treatment with finerenone, a nonsteroidal mineralocorticoid receptor antagonist, significantly reduced albuminuria in people with type 1 diabetes and chronic kidney disease, signaling the potential for the first new therapy in decades for this high-risk group.
In a global phase 3 study, presented at Kidney Week, finerenone reduced albuminuria by approximately 25% versus placebo, according to investigator Hiddo Lambers Heerspink, PhD, PharmD, of University Medical Center Groningen, Netherlands.
Treatment was well tolerated and safe, with modest effects on concentrations of potassium in the blood, according to the investigator, who presented findings of the FINE-ONE trial at the meeting’s opening plenary session.
This analysis provides vital evidence, according to Dr. Heerspink, for the efficacy and safety of finerenone in patients with chronic kidney disease and type 1 diabetes.
As such, it may result in finerenone becoming the first treatment in 30 years to receive regulatory approval for this group of patients, he said.
“Finerenone is the first novel therapy with a favorable benefit/risk profile for people with type 1 diabetes and chronic kidney disease since the introduction of renin-angiotensin-aldosterone system inhibitors,” Dr. Heerspink said in a news release highlighting the study as a high-impact clinical trial.
Finerenone is one of multiple drugs introduced in recent years for the treatment of chronic kidney disease in people with type 2 diabetes.
By contrast, people with type 1 diabetes and associated chronic kidney disease have more limited treatment options, as they have been excluded from past clinical trials of potentially beneficial treatments, including finerenone.
Spironolactone, a steroidal mineralocorticoid receptor antagonist, has been shown to reduce albuminuria in small clinical studies. However, it was not approved in chronic kidney disease, in part because of an unfavorable safety/efficacy profile, Dr. Heerspink and co-authors wrote in a 2023 journal article describing the rationale and design of the FINE-ONE trial.
In that article, they reported the primary endpoint of FINE-ONE, relative change in urine albumin/creatinine ratio (UACR) over 6 months. They describe UACR as a “bridging biomarker,” noting that in the previous type 2 diabetes trials, UACR was associated with the efficacy of finerenone on kidney outcomes.
Use of UACR as a bridging biomarker may set a precedent for future studies in people with type 1 diabetes and chronic kidney disease, a patient population where “new therapies are highly needed,” investigators said in the report.
“Based on regulatory authority feedback, UACR can be used as a bridging biomarker for kidney outcomes to support registration of finerenone in type 1 diabetes, provided necessary criteria are met,” the authors wrote at the time.
The results of the FINE-ONE study presented at Kidney Week included 242 patients randomized to finerenone or placebo. The roughly 25% reduction in albuminuria over 6 months, as measured by UACR, is expected to translate to less kidney failure in these patients, according to Dr. Heerspink.
Results of this study, conducted at 82 hospitals in 9 countries, should encourage further research on new medications for patients at high risk of both kidney and heart disease, he added.
Disclosures
Hiddo Lambers Heerspink, PhD, PharmD, and co-authors disclosed commercial support from Bayer AG.
References
Heerspink HJL, Cherney D, Rossing P, et al. TH-OR082 Finerenone in CKD and type 1 diabetes [abstract]. Presented at: American Society of Nephrology Kidney Week 2025; November 6–9, 2025; Houston, TX.
Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Diabetes Res Clin Pract 2023; 204:110908. doi:10.1016/j.diabres.2023.110908