Kerendia: Can It Protect Kidneys in Type 1 Diabetes?

What does Kerendia's approval mean for type 1 diabetes?

Kerendia's expanded indication addresses a longstanding treatment gap. Bayer describes it as the first new FDA-approved treatment for this population in more than three decades. Finerenone blocks the mineralocorticoid receptor, whose excessive activation contributes to harmful processes in the kidneys and heart. The medicine was already approved for kidney disease associated with type 2 diabetes. [Bayer approval announcement](https://www.bayer.com/en-us/united-states/news-and-stories/2026/treatment-forchronic-kidney-disease-and-type-1-diabetes).

Kidney damage can develop gradually as high blood glucose and high blood pressure injure small blood vessels. Because early disease often causes no symptoms, blood and urine testing matter: estimated glomerular filtration rate, or eGFR, assesses filtration, while urinary albumin signals protein leakage. Glucose management and blood pressure treatment remain central to kidney protection. [NIDDK explanation of diabetic kidney disease](https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/diabetic-kidney-disease).

What did the FINE-ONE clinical trial actually show?

The randomized phase 3 trial enrolled 242 adults with type 1 diabetes, impaired kidney health and substantial albuminuria. Participants received finerenone or placebo alongside an ACE inhibitor or an angiotensin receptor blocker. The primary analysis found a 25% relative reduction in urinary albumin-to-creatinine ratio, or UACR, compared with placebo. Bayer funded the study, which was published in the New England Journal of Medicine. [FINE-ONE trial publication](https://pubmed.ncbi.nlm.nih.gov/41780000/).

That result requires careful interpretation: a 25% reduction in UACR does not mean a 25% reduction in kidney failure. The approval connects the albuminuria findings with earlier finerenone trials in type 2 diabetes, where kidney outcomes were measured directly. This supports an expectation of protection in type 1 diabetes, but FINE-ONE does not quantify how many patients will avoid dialysis or how long progression might be delayed. [Bayer explanation of the supporting evidence](https://www.bayer.com/en-us/united-states/news-and-stories/2026/treatment-forchronic-kidney-disease-and-type-1-diabetes).

What safety checks are needed before starting Kerendia?

Elevated blood potassium, called hyperkalemia, is a central safety consideration. In FINE-ONE, it occurred in 10.1% of finerenone recipients and 3.3% of placebo recipients; two participants stopped finerenone because of it. These findings make laboratory follow-up an essential part of treatment. [FINE-ONE safety results](https://pubmed.ncbi.nlm.nih.gov/41780000/).

The FDA label requires potassium and eGFR assessment before prescribing. Treatment should not begin when potassium exceeds 5.0 mEq/L, and initiation is not recommended below an eGFR of 25 mL/min/1.73 m². Potassium should be checked four weeks after starting or adjusting the dose, then periodically. Strong CYP3A4 inhibitors and adrenal insufficiency are contraindications; grapefruit should be avoided. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215341s011lbl.pdf).