What is the recommended treatment regimen for an adult patient with type 2 diabetes (T2D) and chronic kidney disease (CKD) using Finerenone?

Finerenone Treatment Regimen for Adults with Type 2 Diabetes and Chronic Kidney Disease

Finerenone should be initiated at 10 mg once daily for patients with eGFR 25-60 mL/min/1.73 m² or 20 mg once daily for patients with eGFR >60 mL/min/1.73 m², provided they have persistent albuminuria (ACR ≥30 mg/g) despite maximum tolerated RAS inhibitor therapy and serum potassium <4.8 mmol/L. 1

Patient Selection Criteria

Before initiating finerenone, confirm the following eligibility requirements:

• Albuminuria threshold: ACR ≥30 mg/g (≥3 mg/mmol) despite maximum tolerated dose of ACE inhibitor or ARB 1
• Kidney function: eGFR ≥25 mL/min/1.73 m² 1
• Potassium level: Serum potassium must be <4.8 mmol/L at screening 1
• Background therapy: Patient must already be on maximum tolerated RAS inhibitor therapy 1

Dosing Algorithm

Initial Dose Selection

The starting dose is determined by baseline eGFR 1, 2:

• eGFR 25-60 mL/min/1.73 m²: Start 10 mg once daily 1, 2
• eGFR >60 mL/min/1.73 m²: Start 20 mg once daily 1, 2

Dose Titration

After 4 weeks of treatment, uptitrate from 10 mg to 20 mg once daily if both conditions are met 1, 2:

• Serum potassium remains ≤4.8 mmol/L
• eGFR remains stable

Potassium Monitoring Protocol

Critical monitoring schedule to prevent hyperkalemia-related complications 2:

Monitoring Frequency

• Baseline: Check potassium before initiation 2
• 1 month: Recheck after starting finerenone 2
• Maintenance: Monitor every 4 months during ongoing therapy 2

Potassium-Based Management Algorithm

Potassium Level	Action Required
≤4.8 mmol/L	Continue current dose or uptitrate 10 mg to 20 mg [2]
4.9-5.5 mmol/L	Continue current dose, increase monitoring frequency to every 4 months [2]
>5.5 mmol/L	Hold finerenone immediately, adjust diet/medications, recheck potassium, restart at 10 mg when potassium ≤5.0 mmol/L [2]

Clinical Benefits Supporting Use

Finerenone provides dual cardiorenal protection in this population:

Cardiovascular Protection

• 13-14% reduction in composite cardiovascular outcomes (cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure) 1, 2, 3
• 29% reduction in heart failure hospitalizations specifically (HR 0.71,95% CI 0.56-0.90) 4, 3, 5
• Particularly effective at preventing new-onset heart failure in patients without prior HF history 5

Kidney Protection

• 23% reduction in composite kidney outcomes (kidney failure, sustained ≥57% decrease in eGFR, or renal death; HR 0.77,95% CI 0.67-0.88) 1, 2
• 20% reduction in progression to kidney failure requiring dialysis or transplantation (HR 0.80,95% CI 0.64-0.99) 1
• 36% reduction in end-stage kidney disease 4

Therapeutic Positioning in Treatment Algorithm

KDIGO 2022 guidelines position finerenone as additional risk-based therapy after first-line agents 1:

First-Line Foundation

1. SGLT2 inhibitor (initiate if eGFR ≥20) 1
2. Metformin (if eGFR ≥30) 1
3. RAS inhibitor at maximum tolerated dose 1
4. Moderate- or high-intensity statin 1

When to Add Finerenone

Add finerenone as additional risk-based therapy when 1, 2:

• ACR remains ≥30 mg/g despite maximum tolerated RAS inhibitor
• Potassium is normal (<4.8 mmol/L)
• Patient is already on SGLT2 inhibitor (finerenone provides complementary benefits) 2, 3

Important positioning note: While SGLT2 inhibitors are prioritized over finerenone due to larger effect sizes on kidney and cardiovascular outcomes, finerenone should be added if albuminuria persists despite SGLT2 inhibitor therapy or if SGLT2 inhibitors are not tolerated 2. The combination of RAS inhibitor + SGLT2 inhibitor + finerenone provides complementary cardiorenal protection 2, 3.

Safety Considerations and Common Pitfalls

Hyperkalemia Risk

While hyperkalemia is the primary safety concern, the actual risk of treatment discontinuation is relatively low:

• Hyperkalemia incidence: 14% with finerenone vs 6.9% with placebo 1
• Permanent discontinuation: Only 1.7% vs 0.6% with placebo 1
• No deaths attributed to hyperkalemia in clinical trials over 3 years 1

Critical Pitfall to Avoid

Do not withhold finerenone solely due to fear of hyperkalemia in appropriate candidates. The risk is manageable with proper monitoring, and the cardiovascular and kidney benefits substantially outweigh the hyperkalemia risk in patients meeting eligibility criteria 1, 6. Consider using oral potassium binders to enable continuation of therapy rather than discontinuation 6.

When to Refer to Nephrology

Refer to nephrology when 1, 4:

• eGFR <30 mL/min/1.73 m² (for advanced CKD management and renal replacement therapy discussion)
• Continuously rising ACR or declining eGFR despite optimal therapy
• Recurrent hyperkalemia requiring dose adjustments
• Uncertainty about kidney disease etiology

Evidence Quality and Strength

The recommendation for finerenone is based on high-quality evidence from two large Phase 3 trials (FIDELIO-DKD and FIGARO-DKD) and their pooled analysis (FIDELITY), which together enrolled over 13,000 patients with type 2 diabetes and CKD 1. Both trials demonstrated consistent benefits across the spectrum of CKD severity (eGFR 25-90 mL/min/1.73 m²) and albuminuria levels 1, 7. Finerenone is currently the only nonsteroidal MRA with proven clinical kidney and cardiovascular benefits 1.