What is the treatment approach for chronic kidney disease using Kerendia (finerenone) in patients with type 2 diabetes?

Treatment Approach for Chronic Kidney Disease Using Kerendia (Finerenone) in Patients with Type 2 Diabetes

Finerenone (Kerendia) should be added to the treatment regimen of patients with type 2 diabetes and chronic kidney disease with albuminuria who are already on maximum tolerated doses of renin-angiotensin system inhibitors to reduce kidney disease progression and cardiovascular events. 1

Patient Selection Criteria

Appropriate Candidates for Finerenone

• Patients with type 2 diabetes and CKD with:
  • Albuminuria (urine albumin-to-creatinine ratio ≥30 mg/g) 1
  • eGFR ≥25 mL/min/1.73 m² 1
  • Normal serum potassium (<4.8 mmol/L) 1
  • Already on maximum tolerated dose of ACE inhibitor or ARB 1

Dosing Algorithm

• Initial dosing:
  • eGFR 25-60 mL/min/1.73 m²: Start with 10 mg once daily 1
  • eGFR ≥60 mL/min/1.73 m²: Start with 20 mg once daily 1
• Dose titration:
  • Consider increasing dose from 10 mg to 20 mg after 1 month if:
    • Serum potassium remains ≤4.8 mmol/L
    • eGFR remains stable 1

Monitoring Requirements

• Before initiation:

  • Baseline eGFR
  • Serum potassium level
  • Assessment for potential drug-drug interactions 2

• Follow-up monitoring:

  • Serum potassium levels regularly, especially in first months of treatment
  • eGFR to assess kidney function
  • Signs/symptoms of hyperkalemia 2

Clinical Benefits

Finerenone has demonstrated significant benefits in two major trials (FIDELIO-DKD and FIGARO-DKD) with consistent findings in the combined FIDELITY analysis:

1. Kidney outcomes:

   • 23% reduction in the composite kidney outcome (kidney failure, sustained ≥57% decrease in eGFR, or renal death) 1
   • 20% reduction in progression to end-stage kidney disease 1

2. Cardiovascular outcomes:

   • 14% reduction in cardiovascular composite outcome (cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure) 1
   • 32% reduction in new-onset heart failure 3
   • 29% reduction in first hospitalization for heart failure 3

Integration with Other Treatments

Finerenone should be part of a comprehensive treatment approach:

1. First-line therapies (should already be in place):

   • SGLT2 inhibitor (if eGFR ≥20 mL/min/1.73 m²)
   • Metformin (if eGFR ≥30 mL/min/1.73 m²)
   • RAS inhibitor (ACEi or ARB) at maximum tolerated dose
   • Moderate or high-intensity statin 1

2. Add finerenone when:

   • Patient has albuminuria (UACR ≥30 mg/g)
   • Normal serum potassium
   • Already on maximum tolerated RAS inhibitor 1

Safety Considerations and Pitfalls

Hyperkalemia Risk

• Most common adverse effect: hyperkalemia (14% with finerenone vs 6.9% with placebo) 1
• Risk factors for hyperkalemia:
  • Advanced kidney disease
  • Concomitant use of other potassium-raising medications
  • High potassium diet

Mitigation Strategies

• Screen for baseline hyperkalemia before initiating therapy
• Start with lower dose (10 mg) in patients with more advanced CKD
• Regular monitoring of serum potassium levels
• Patient education regarding dietary potassium intake
• Only 1.7% of patients in clinical trials permanently discontinued finerenone due to hyperkalemia 1

Drug Interactions

• Avoid concomitant use with strong CYP3A4 inhibitors
• Consider potential interactions with other medications that affect potassium levels 2

Special Considerations

• Referral to nephrology: Consider referral when eGFR <30 mL/min/1.73 m² or for difficult management issues including hyperkalemia 1

• Combination therapy: Emerging evidence suggests potential additive benefits when combining finerenone with SGLT2 inhibitors, though this is still being investigated in the CONFIDENCE trial 4

• Reimbursement: In some regions, reimbursement may be conditional on combination with a renin-angiotensin system blocker 5