Kerendia (Finerenone) is NOT Currently Approved for Type 1 Diabetes
No, you cannot routinely prescribe Kerendia for type 1 diabetes—it is FDA-approved exclusively for chronic kidney disease associated with type 2 diabetes and for heart failure with LVEF ≥40%. 1
FDA Indication is Specific to Type 2 Diabetes
The FDA label explicitly states that Kerendia is indicated for CKD associated with type 2 diabetes (T2DM) only 1. This is not an oversight—the approval was based on large outcome trials (FIDELIO-DKD and FIGARO-DKD) that enrolled only patients with type 2 diabetes.
Guideline Recommendations Align with Type 2 Diabetes Only
The KDIGO 2022 guidelines clearly specify that nonsteroidal mineralocorticoid receptor antagonists (finerenone) are recommended only for patients with T2D and persistent albuminuria (>30 mg/g) 2. Their treatment algorithm explicitly labels finerenone as "T2D only" while distinguishing it from therapies applicable to both T1D and T2D 2.
The 2025 BMJ guideline similarly addresses finerenone exclusively in the context of type 2 diabetes, with a weak recommendation against its use even in moderate-risk T2D patients with CKD, citing limited benefit relative to harms (particularly hyperkalemia) 3.
Emerging Evidence in Type 1 Diabetes
However, recent data suggests this may change: The FINE-ONE trial (2026) demonstrated that finerenone significantly reduced albuminuria by 25% compared to placebo in adults with type 1 diabetes and CKD over 6 months 4. This phase 3 trial enrolled 242 participants with T1D, eGFR 25-90 mL/min/1.73m², and significant albuminuria (UACR 200-5000 mg/g) who were already on ACE inhibitors or ARBs 4.
Key Findings from FINE-ONE:
- Primary outcome met: Urinary albumin-to-creatinine ratio decreased 34% with finerenone vs. 12% with placebo (p<0.001) 4
- Safety concern: Hyperkalemia occurred in 10.1% with finerenone vs. 3.3% with placebo; only 1.7% discontinued due to hyperkalemia 4
- eGFR decline: Greater initial decline with finerenone (-5.6 vs. -2.7 mL/min/1.73m²), but values approached baseline during washout, suggesting hemodynamic rather than structural kidney injury 4
Clinical Implications:
This trial used UACR as a "bridging biomarker" to support potential regulatory approval in T1D, based on the established relationship between UACR reduction and hard kidney outcomes demonstrated in the type 2 diabetes trials 5. The trial was specifically designed with regulatory authority input to support registration of finerenone for T1D 5.
Current Clinical Practice
Until regulatory approval is obtained for type 1 diabetes:
- Finerenone remains off-label for T1D patients
- Standard of care for T1D with CKD continues to be ACE inhibitors or ARBs as first-line therapy 2
- SGLT2 inhibitors now have evidence in T1D for certain patients (though with careful monitoring for diabetic ketoacidosis)
If considering off-label use (which would require careful shared decision-making and informed consent):
- Limit to patients with T1D, CKD (eGFR 25-90), significant albuminuria (UACR ≥200 mg/g), and already on maximally tolerated ACE inhibitor/ARB
- Monitor potassium closely: check at 4 weeks, then periodically
- Do not initiate if potassium >5.0 mEq/L 1
- Expect hyperkalemia risk approximately 3-fold higher than placebo 4
Common Pitfall to Avoid
Do not assume all diabetes medications apply equally to type 1 and type 2 diabetes. The pathophysiology overlaps but differs significantly, and regulatory approvals are indication-specific. The FDA label is legally binding for approved indications, and prescribing off-label carries additional liability and requires explicit documentation of rationale and patient consent.