Can finerenone be initiated in a patient with end‑stage renal disease on chronic dialysis for refractory hypertension or heart failure?

Finerenone Should Not Be Initiated in Patients with End-Stage Renal Disease on Chronic Dialysis

Finerenone is contraindicated in patients with end-stage renal disease (ESRD) on chronic dialysis, regardless of the indication, because the landmark trials specifically excluded patients with eGFR <25 mL/min/1.73 m², and there is no established dosing, efficacy, or safety data for this population. 1

Evidence Base and Trial Exclusion Criteria

The pivotal FIDELIO-DKD and FIGARO-DKD trials that established finerenone's efficacy enrolled only patients with eGFR ≥25 mL/min/1.73 m² 1. These trials demonstrated:

• 23% reduction in composite kidney outcomes (kidney failure, ≥57% eGFR decline, or renal death) with HR 0.77 (95% CI 0.67-0.88) 1
• 14% reduction in cardiovascular events (CV death, nonfatal MI, nonfatal stroke, or HF hospitalization) with HR 0.86 (95% CI 0.78-0.95) 1
• 36% reduction in progression to end-stage kidney disease with HR 0.64 (95% CI 0.41-0.995) 1

However, these benefits apply only to patients with CKD stages 2-4, not those already in ESRD 1.

Guideline-Based Contraindications

KDIGO 2024 Guidelines

The most recent KDIGO guidelines explicitly state that finerenone should be used in adults with:

• eGFR >25 mL/min/1.73 m² 2
• Type 2 diabetes with albuminuria (>30 mg/g) 2
• Normal serum potassium concentration 2
• Maximum tolerated dose of RAS inhibitor 2

Patients with eGFR <25 mL/min/1.73 m² or on dialysis do not meet eligibility criteria 2.

KDIGO 2022 Guidelines

The 2022 guidelines similarly recommend finerenone only for patients with eGFR ≥25 mL/min/1.73 m² 2. The evidence from FIDELITY showed kidney failure prevention (HR 0.80; 95% CI 0.64-0.99), but this was in patients before reaching ESRD, not those already on dialysis 2.

Dosing Algorithm Confirms Exclusion

The approved dosing protocol has no recommendations for eGFR <25 mL/min/1.73 m² 1:

• eGFR 25-60 mL/min/1.73 m²: Start 10 mg daily 1
• eGFR >60 mL/min/1.73 m²: Start 20 mg daily 1
• eGFR <25 mL/min/1.73 m² or dialysis: No dosing available 1

Hyperkalemia Risk in ESRD

Hyperkalemia is the primary safety concern with finerenone, occurring in 14% vs 6.9% with placebo in trial populations with eGFR ≥25 mL/min/1.73 m² 2, 1. In dialysis patients, this risk would be substantially magnified due to:

• Impaired potassium excretion between dialysis sessions 1
• Concurrent use of RAS inhibitors (required before finerenone) 2
• Lack of safety data in this population 1

Alternative Approaches for Refractory Hypertension or Heart Failure in Dialysis

For Refractory Hypertension

Steroidal MRAs (spironolactone or eplerenone) may be used cautiously for refractory hypertension in dialysis patients, but require intensive potassium monitoring 2. The KDIGO guidelines note that "a steroidal MRA may be used for treatment of heart failure, hyperaldosteronism, or refractory hypertension, but may cause hyperkalemia or a reversible decline in glomerular filtration, particularly among people with a low GFR" 2.

For Heart Failure

Standard heart failure therapies (beta-blockers, diuretics if residual urine output, volume management through dialysis) remain the mainstay 2. The FINEARTS-HF trial examined finerenone in heart failure with preserved ejection fraction but excluded patients with eGFR <25 mL/min/1.73 m² 3.

Common Pitfalls to Avoid

• Do not extrapolate trial data to ESRD populations: The cardiovascular and renal benefits demonstrated in FIDELIO-DKD and FIGARO-DKD do not apply to dialysis patients 1
• Do not assume "some benefit is better than none": Without safety data, the hyperkalemia risk may outweigh any theoretical benefit 1
• Do not confuse steroidal and nonsteroidal MRAs: While steroidal MRAs have limited data in dialysis for specific indications, nonsteroidal MRAs like finerenone have none 2, 1

Appropriate Nephrology Referral

Patients should have been referred to nephrology when eGFR fell below 30 mL/min/1.73 m² (stage 4 CKD) for discussion of renal replacement therapy 1. At that point, finerenone could have been considered if eGFR was still ≥25 mL/min/1.73 m² 2, 1. Once on dialysis, this window has closed.