FDA Approves Finerenone for CKD Associated With Type 1 Diabetes

Key Facts

• The FDA approved KERENDIA to reduce UACR, which is expected to slow chronic kidney disease progression in adults with CKD associated with T1D.1 This approval is important for patients, as it is the first proven therapeutic advance in CKD associated with T1D in more than 30 years.
• Approval was supported by data from the Phase III FINE-ONE clinical trial in adult patients with CKD associated with T1D. It was also supported by Phase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD associated with type 2 diabetes (T2D).
• Approximately 20-30% of people in the U.S. with T1D also have CKD which puts them at risk of kidney disease progression and kidney failure.
• KERENDIA is also approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.
• In addition, KERENDIA is approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.

Why This FDA Approval Matters for Patients and Physicians

“For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression,"2 said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Executive Committee. "The approval of KERENDIA to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

KERENDIA, a once-daily, oral treatment option, is the only MRA indicated for adults with CKD associated with either T2D or T1D.

“This approval builds on evidence linking reductions in UACR with improved kidney outcomes in KERENDIA’s clinical trial program in chronic kidney disease associated with type 2 diabetes,”1 said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “KERENDIA’s third indication validates the breadth of its clinical trial program across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved.”

FINE-ONE Clinical Trial Results

FINE-ONE (NCT05901831) was a pivotal, global, randomized, prospective, double-blind, placebo-controlled, multicenter, Phase III study in adult patients with CKD associated with T1D. FINE-ONE enrolled 242 adult participants with the primary objective to demonstrate whether the addition of KERENDIA, 10 mg or 20 mg once daily, to standard of care was superior to placebo in reducing UACR over six months (averaged over months 3 and 6).1 UACR is an important marker of CKD progression.2

The results showed:

• KERENDIA significantly reduced UACR vs. placebo over 6 months (p=0.0001). Reductions in UACR were observed as early as Month 3 and were sustained through Month 6.
  • At Month 3, KERENDIA reduced UACR compared to placebo by 22% (ratio of Least Square Geometric Mean Ratio [LSGMR] of 0.78; 95% CI: 0.68, 0.90).
  • At Month 6, KERENDIA reduced UACR compared to placebo by 28% (ratio of LSGMR of 0.72; 95% CI: 0.60, 0.86).
• Safety and tolerability were consistent with the existing evidence for KERENDIA in adults with CKD associated with T2D.1
  • The rate of treatment-emergent adverse events was 47.1% for those treated with KERENDIA and 49.2% for placebo.
  • The rate of treatment-emergent serious adverse events was 11.8% for KERENDIA and 11.5% for placebo.
  • Hyperkalemia, an adverse event of special interest, was observed more frequently with KERENDIA (10.1%) compared to placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively.

Detailed FINE-ONE trial results were presented at the American Society of Nephrology (ASN) Kidney Week 2025 and published in the New England Journal of Medicine.

Why Managing UACR Matters

UACR is a modifiable risk factor associated with chronic kidney disease progression.2 In the FIDELIO-DKD and FIGARO-DKD trials, reductions in UACR with KERENDIA were shown to be associated with improved kidney outcomes in adults with CKD and T2D.1 Together with the FINE-ONE results, this evidence supported the use of UACR to bridge KERENDIA’s established kidney outcomes evidence from CKD associated with T2D to patients with CKD associated with T1D.

KERENDIA’s Approved Indications

Since 2021, KERENDIA has been approved by the FDA to reduce the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction, sustained eGFR decline and end-stage kidney disease in adult patients with CKD associated with T2D.

In July 2025, KERENDIA received FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with HF LVEF ≥40%.

Now, KERENDIA is also approved by the FDA to reduce UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with T1D.