Is Kerendia (finerenone) recommended for patients with type 1 diabetes?

Finerenone (Kerendia) is NOT Recommended for Type 1 Diabetes

Finerenone (Kerendia) is currently not recommended for patients with type 1 diabetes as there is insufficient evidence supporting its use in this population, and it is only approved for type 2 diabetes with chronic kidney disease.

Current Evidence and Recommendations

The 2022 KDIGO Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease specifically addresses the use of nonsteroidal mineralocorticoid receptor antagonists (ns-MRAs) such as finerenone:

• Finerenone is recommended only for patients with type 2 diabetes who have persistent albuminuria despite maximum tolerated RAS inhibitor therapy and have non-elevated serum potassium 1
• The guideline explicitly states that finerenone's benefits have been demonstrated in type 2 diabetes, with no mention of type 1 diabetes 1
• In Figure 3 of the KDIGO guideline, finerenone (nonsteroidal MRA) is specifically listed under "T2D only" treatments, not under "All patients (T1D and T2D)" 1

Ongoing Research for Type 1 Diabetes

There is emerging research exploring finerenone's potential in type 1 diabetes:

• The FINE-ONE trial (NCT05901831) is currently investigating finerenone in adults with type 1 diabetes and chronic kidney disease 2
• This phase III trial will evaluate the efficacy and safety of finerenone in approximately 220 adults with type 1 diabetes who have albuminuria and reduced eGFR 2
• The primary endpoint is relative change in urine albumin/creatinine ratio (UACR) over 6 months 2
• If successful, finerenone "could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years" 2

Current Management for Type 1 Diabetes with CKD

For patients with type 1 diabetes and chronic kidney disease, current guidelines recommend:

1. RAS inhibitors (ACEi or ARB) as first-line therapy for those with hypertension and albuminuria 1
2. Insulin therapy remains the cornerstone of glycemic management in type 1 diabetes 1
3. Lifestyle modifications including smoking cessation 1

Why Finerenone Is Not Yet Recommended for Type 1 Diabetes

1. Lack of clinical evidence: The large randomized controlled trials (FIDELIO-DKD and FIGARO-DKD) that demonstrated finerenone's benefits included only patients with type 2 diabetes 1, 3

2. Regulatory approval status: Finerenone is currently only approved for treatment of CKD with albuminuria in adults with type 2 diabetes 4

3. Different pathophysiology: While T1D and T2D share common pathological features of CKD, there are important differences in disease mechanisms that require specific evidence 5

Future Directions

A recent review suggests that finerenone may have potential in T1D patients with CKD because:

• Both T1D and T2D share common pathological features of CKD driven by hemodynamic dysfunction and metabolic disturbances 5
• The mineralocorticoid receptor is involved in both conditions, promoting oxidative stress, inflammation, and fibrosis 5

However, until the results of the FINE-ONE trial are available and regulatory approval is obtained, finerenone should not be used in patients with type 1 diabetes.

Clinical Implications

For clinicians managing patients with type 1 diabetes and CKD:

• Continue to follow established guidelines for T1D management
• Consider enrolling eligible patients in clinical trials investigating finerenone for T1D
• Monitor for updates to guidelines as new evidence emerges from the FINE-ONE trial
• Focus on optimizing insulin therapy, blood pressure control with RAS inhibitors, and lifestyle modifications

In conclusion, while finerenone shows promise for patients with type 1 diabetes and CKD, current evidence and guidelines do not support its use in this population at this time.