Kerendia (Finerenone) in Non-Diabetic Kidney Disease
Currently, Kerendia (finerenone) is not approved or recommended for non-diabetic kidney disease as its proven benefits are limited to patients with type 2 diabetes and chronic kidney disease with albuminuria. 1
Current Evidence and Approval Status
Finerenone is a non-steroidal mineralocorticoid receptor antagonist that has demonstrated significant cardiorenal protective effects, but specifically in the context of diabetic kidney disease:
Finerenone has been studied extensively in patients with type 2 diabetes and CKD in the FIDELIO-DKD and FIGARO-DKD trials, showing:
Current guidelines from the American Diabetes Association and KDIGO specifically recommend finerenone for patients with type 2 diabetes and CKD with albuminuria (ACR ≥30 mg/g) who are already on maximum tolerated doses of ACE inhibitors or ARBs 1
Emerging Research in Non-Diabetic CKD
While not yet approved for non-diabetic CKD, there is emerging research suggesting potential benefits:
Preclinical Evidence: Recent animal studies have shown that finerenone improves diastolic dysfunction, reduces cardiac fibrosis, and improves cardiac perfusion in a non-diabetic CKD model 3
Ongoing Clinical Trials: The FIND-CKD trial (NCT05047263) is currently investigating finerenone in adults with non-diabetic CKD. This phase 3 trial includes 1,584 patients with:
- UACR ≥200-≤3500 mg/g
- eGFR ≥25-<90 ml/min/1.73 m²
- Most common causes: chronic glomerulonephritis (57.0%) and hypertensive/ischemic nephropathy (29.0%)
- IgA nephropathy representing 26.3% of the total population 4
Theoretical Mechanism: Activation of the mineralocorticoid receptor, with consequent inflammation and fibrosis, is likely operative as a pathogenetic mediator in both diabetic and non-diabetic kidney disease 5
Clinical Implications and Monitoring
If considering off-label use (which cannot be recommended until trial results are available):
Patient Selection: Similar to diabetic CKD criteria, patients would need:
- eGFR ≥25 ml/min/1.73 m²
- Serum potassium <4.8 mmol/L
- No adrenal insufficiency 1
Hyperkalemia Risk: This is the primary adverse effect of finerenone:
- In diabetic CKD trials, hyperkalemia occurred in 10.8% of finerenone patients vs. 5.3% with placebo
- Monitoring of serum potassium at baseline, 1 month after initiation, and every 4 months thereafter would be essential 1
Future Directions
The FIND-CKD trial will provide crucial data on the efficacy and safety of finerenone in non-diabetic CKD. Additionally, the FIONA program is investigating finerenone in children with glomerular and non-glomerular CKD 5.
Until these trials are completed and regulatory approval is obtained, finerenone should only be used for its approved indication in type 2 diabetes with CKD, as recommended by current guidelines 6, 1.