What is finerenone, used to treat patients with chronic kidney disease (CKD) and type 2 diabetes?

What is Finerenone

Finerenone is a selective nonsteroidal mineralocorticoid receptor antagonist (MRA) approved for treating adults with chronic kidney disease (CKD) and type 2 diabetes who have persistent albuminuria despite maximum tolerated renin-angiotensin system (RAS) inhibitor therapy. 1, 2

Mechanism and Drug Class

Finerenone represents a novel class of nonsteroidal MRAs that selectively blocks the mineralocorticoid receptor, addressing aldosterone-mediated pathological overactivation and inflammation that drives CKD progression. 3 Unlike steroidal MRAs (spironolactone, eplerenone), finerenone has a distinct pharmacological profile with improved selectivity and reduced risk of hormonal side effects such as gynecomastia. 3, 4

Primary Clinical Indication

Finerenone should be initiated in adults with type 2 diabetes and CKD who meet all of the following criteria: 2

• Persistent albuminuria (UACR ≥30 mg/g) despite maximum tolerated dose of ACE inhibitor or ARB 1, 2
• eGFR ≥25 mL/min/1.73 m² (CKD stages 2-4) 2, 5
• Serum potassium ≤4.8 mmol/L at baseline 2, 6

Cardiovascular and Kidney Benefits

Finerenone provides dual cardiorenal protection with robust evidence from two landmark phase 3 trials (FIDELIO-DKD and FIGARO-DKD): 7, 8

• Reduces cardiovascular events by 13-14% (HR 0.86-0.87), including cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalization 2, 6, 7
• Reduces heart failure hospitalization by 29% (HR 0.71,95% CI 0.56-0.90), with particular benefit in preventing new-onset heart failure 2, 6
• Reduces kidney disease progression by 18-23% (composite of kidney failure, sustained ≥40-57% eGFR decrease, or renal death) 2, 5, 8
• Reduces progression to end-stage kidney disease by 36% (HR 0.64,95% CI 0.41-0.995) 5

Dosing Algorithm

Starting dose is determined by baseline eGFR: 2, 6

• eGFR 25-60 mL/min/1.73 m²: Start 10 mg once daily 2, 5
• eGFR >60 mL/min/1.73 m²: Start 20 mg once daily 2, 5

Dose uptitration after 4 weeks: 2

• If serum potassium remains ≤4.8 mmol/L and medication is well-tolerated, uptitrate from 10 mg to 20 mg daily 1, 5

Treatment Sequencing in Clinical Practice

The recommended treatment hierarchy for cardiorenal protection follows this algorithm: 2, 5

1. First-line foundation: Maximum tolerated dose of ACE inhibitor or ARB 2, 5
2. Second-line priority: SGLT2 inhibitor (prioritized over finerenone due to larger effects on kidney and cardiovascular outcomes) 2, 5
3. Third-line consideration: Finerenone if persistent albuminuria despite SGLT2 inhibitor OR if SGLT2 inhibitor intolerance 2, 5

Finerenone may be added to both RAS inhibitor and SGLT2 inhibitor for complementary cardiorenal protection in patients with persistent albuminuria. 2

Potassium Monitoring Protocol

Hyperkalemia is the primary safety concern requiring vigilant monitoring: 6, 5

Monitoring schedule: 2, 5

• Baseline: Verify potassium ≤4.8 mmol/L before initiation 2, 5
• 1 month after initiation: Recheck potassium 2, 5
• Every 4 months during maintenance 2, 5

Management based on potassium levels: 2, 5

Potassium Level	Action
≤4.8 mmol/L	Continue current dose or uptitrate to 20 mg if on 10 mg [2]
4.9-5.5 mmol/L	Continue current dose, monitor every 4 months [2]
>5.5 mmol/L	Hold finerenone, adjust diet/medications, restart at 10 mg when ≤5.0 mmol/L [1,2]

Safety Profile

In pooled trial data, hyperkalemia occurred in 10.8-14% of finerenone patients versus 5.3-6.9% with placebo. 6, 5 However, severe hyperkalemia requiring permanent discontinuation was rare (1.2-2.3% vs 0.4-0.9% placebo), and no deaths from hyperkalemia occurred over 3 years of follow-up. 5, 8, 4

Finerenone has no significant effect on HbA1c, body weight, or sexual side effects including gynecomastia, and only modest effects on blood pressure. 4

Important Clinical Caveats

Do not initiate finerenone in patients with: 5

• eGFR <25 mL/min/1.73 m² or end-stage renal disease (no established dosing or safety data) 5
• Baseline potassium >4.8 mmol/L 2, 5

Risk factors for hyperkalemia include: 5

• Lower eGFR (particularly <45 mL/min/1.73 m²) 5
• Beta-blocker use 5

Protective factor: SGLT2 inhibitor co-administration reduces hyperkalemia risk 5

Guideline Integration

Finerenone is now incorporated into major guidelines including KDIGO 2022, American Diabetes Association 2024, and American College of Cardiology recommendations as add-on therapy for patients with persistent albuminuria despite standard care. 1, 5 The ADA/KDIGO consensus identifies finerenone as the only nonsteroidal MRA with proven clinical kidney and cardiovascular benefits. 1