Can Kerendia (finerenone) be used in patients with type 1 diabetes?

Kerendia (Finerenone) is NOT Currently Approved for Type 1 Diabetes

Finerenone is currently approved only for patients with type 2 diabetes and chronic kidney disease, not for type 1 diabetes. 1 All major clinical trials (FIDELIO-DKD, FIGARO-DKD, and FIDELITY) exclusively enrolled patients with type 2 diabetes, and current regulatory approval is limited to this population. 1, 2

Current Evidence Base

Type 2 Diabetes Only

• The KDIGO 2022 guidelines explicitly state that finerenone recommendations apply to "T2D only" while other therapies like RAS inhibitors and statins apply to "All patients (T1D and T2D)." 1
• The landmark trials that established finerenone's efficacy enrolled 13,026 patients, all with type 2 diabetes and CKD. 2
• Current FDA approval and all major guideline recommendations (KDIGO, ADA) specify type 2 diabetes as the indicated population. 1, 3

Ongoing Research in Type 1 Diabetes

• The FINE-ONE trial (NCT05901831) is currently investigating finerenone in approximately 220 adults with type 1 diabetes and CKD. 4
• This is a 7.5-month phase III trial examining patients with type 1 diabetes, UACR ≥200-<5000 mg/g, and eGFR ≥25-<90 mL/min/1.73 m². 4
• The primary endpoint is relative change in UACR from baseline over 6 months, using UACR as a bridging biomarker based on regulatory authority feedback. 4
• If successful, finerenone could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years. 4

Clinical Algorithm for Current Practice

For Type 1 Diabetes Patients with CKD:

• Do NOT prescribe finerenone - it is not approved for this indication. 1
• Focus on evidence-based therapies that apply to both T1D and T2D:
  • RAS inhibitor (ACE inhibitor or ARB) at maximum tolerated dose if hypertension is present. 1
  • Moderate- or high-intensity statin. 1
  • Blood pressure control targeting individualized BP goals. 1
  • Dihydropyridine calcium channel blocker and/or diuretic as needed for BP control. 1

For Type 2 Diabetes Patients with CKD:

• Finerenone is recommended if:
  • ACR ≥30 mg/g (≥3 mg/mmol) despite maximum tolerated RAS inhibitor. 1, 5
  • eGFR ≥25 mL/min/1.73 m². 1, 5
  • Serum potassium ≤4.8 mmol/L. 1, 5
• Dosing: 10 mg daily if eGFR 25-60 mL/min/1.73 m²; 20 mg daily if eGFR >60 mL/min/1.73 m². 1, 5

Key Caveats

Evidence Gap

• There is currently zero high-quality evidence for finerenone efficacy or safety in type 1 diabetes. 4
• The pathophysiology of diabetic kidney disease differs between type 1 and type 2 diabetes, making extrapolation of benefits uncertain. 6

Hyperkalemia Risk

• In type 2 diabetes trials, hyperkalemia occurred in 14% with finerenone vs 6.9% with placebo. 1
• Type 1 diabetes patients may have different potassium handling, making safety profile unpredictable. 4

Regulatory Status

• Off-label use would lack safety data and dosing guidance specific to type 1 diabetes. 4
• The FINE-ONE trial results are needed before any consideration of use in type 1 diabetes. 4

Bottom line: Wait for FINE-ONE trial results before considering finerenone in type 1 diabetes. Currently, use only evidence-based therapies proven in both diabetes types (RAS inhibitors, statins, BP control). 1, 4