Bayer has 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.
These late-breaking data were presented at the American Society of Nephrology (ASN) Kidney Week 2025 (6–9 November, Houston, USA) by Hiddo Lambers Heerspink (University Medical Center Groningen, Groningen, the Netherlands) and chair of the study’s steering committee.
“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 disease—a research advancement underscored by the trial’s inclusion in the opening plenary session,” said Janet McGill (Washington University School of Medicine, St Louis, USA), co-chair of the study’s steering committee. “By significantly reducing UACR—a key marker of cardiovascular risk and kidney damage—finerenone has the potential to become an important addition to the treatment landscape for patients with type 1 diabetes and chronic kidney disease.”
Since July 2021, Kerendia has been approved to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, Kerendia also received US Food and Drug Administration (FDA) approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) of ≥40%.
FINE-ONE is a pivotal, global, randomised, prospective, double-blind, multicentre, Phase III study in people with T1D and CKD. It enrolled 242 adult participants with the primary objective to demonstrate whether the addition of finerenone, 10 or 20mg once daily, to standard of care is superior to placebo in reducing UACR over six months.
The primary endpoint was the relative change in UACR from baseline over six months. UACR is being investigated as a bridging biomarker to demonstrate delayed kidney disease progression. Elevated UACR is strongly associated with CV risk and kidney disease progression in multiple patient populations, including T1D and T2D. Safety of finerenone was also assessed in the study.
In FINE-ONE, safety and tolerability with finerenone were largely consistent with the existing evidence for people with T2D and CKD. The rate of treatment-emergent adverse events (TEAEs) was 47.1% for those treated with finerenone and 49.2% for placebo. The rate of treatment-emergent serious adverse events (TESAEs) was 11.8% and 11.5%, respectively.
Hyperkalemia, an adverse event of special interest (AESI), was observed more frequently with finerenone (10.1%) compared to placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively.
Bayer plans to submit a supplemental new drug application (sNDA) to the US FDA based on the results of FINE-ONE in 2026.
