What is the FIGARO-DKD (Finerenone in patients with Chronic Kidney Disease and type 2 Diabetes) trial?

FIGARO-DKD Trial Overview

FIGARO-DKD (Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease) was a randomized, double-blind, placebo-controlled trial that demonstrated finerenone significantly reduces cardiovascular events in patients with type 2 diabetes and chronic kidney disease, achieving a 13% reduction in the primary composite cardiovascular endpoint. 1

Trial Design and Population

Study Structure:

• Randomized 7,437 patients with type 2 diabetes and CKD to receive either finerenone or placebo 1
• Double-blind, placebo-controlled, parallel-group, event-driven design conducted across 47 countries 2
• Median follow-up duration of 3.4 years 1
• All participants were on maximum-tolerated doses of renin-angiotensin system inhibitors 1

Eligibility Criteria:

• Patients with UACR 30 to <300 mg/g and eGFR 25-90 mL/min/1.73 m², OR UACR 300-5,000 mg/g and eGFR ≥60 mL/min/1.73 m² 1
• Serum potassium ≤4.8 mmol/L at screening 1
• Patients with heart failure with reduced ejection fraction and uncontrolled hypertension were excluded 1

Baseline Characteristics:

• Mean age 64.1 years, 31% female 1
• Mean eGFR 67.8 mL/min/1.73 m² 1
• Median A1C 7.7%, mean systolic blood pressure 136 mmHg 1

Dosing Protocol

Initial Dosing Strategy:

• Patients with eGFR 25-60 mL/min/1.73 m² received 10 mg once daily 1
• Patients with eGFR >60 mL/min/1.73 m² received 20 mg once daily 1
• Dose escalation from 10 mg to 20 mg was encouraged after 1 month if serum potassium remained ≤4.8 mmol/L and eGFR was stable 1

Primary Cardiovascular Outcomes

Primary Composite Endpoint:

• Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure 1
• Finerenone achieved a 13% relative risk reduction: 12.4% vs. 14.2% in placebo (HR 0.87 [95% CI 0.76-0.98]; P = 0.03) 1
• The benefit was primarily driven by a 29% reduction in heart failure hospitalizations: 3.2% vs. 4.4% in placebo (HR 0.71 [95% CI 0.56-0.90]) 1, 3

New-Onset Heart Failure:

• Finerenone significantly reduced new-onset HF in patients without baseline HF history: 1.9% vs. 2.8% (HR 0.68 [95% CI 0.50-0.93]; P = 0.0162) 3

Secondary Kidney Outcomes

Kidney Protection:

• 36% reduction in end-stage kidney disease: 0.9% vs. 1.3% in placebo (HR 0.64 [95% CI 0.41-0.995]) 1
• Composite kidney endpoint of ≥57% decrease in eGFR sustained over ≥4 weeks, kidney failure, or renal death showed significant benefit (HR 0.77 [95% CI 0.60-0.99]; P = 0.041) 4
• Improvements in albuminuria and eGFR slope were evident across both moderately and severely increased albuminuria subgroups 4

Safety Profile

Hyperkalemia Risk:

• Higher incidence of hyperkalemia with finerenone: 10.8% vs. 5.3% in placebo 1
• Only 1.2% of patients on finerenone discontinued due to hyperkalemia compared to 0.6% in placebo (vs. 0.4% in placebo group overall) 1
• No deaths related to hyperkalemia occurred during the trial 1

Context Within the Finerenone Clinical Program

Complementary to FIDELIO-DKD:

• FIGARO-DKD enrolled patients with earlier-stage CKD compared to FIDELIO-DKD, which focused on more advanced kidney disease 1
• FIDELIO-DKD had kidney outcomes as the primary endpoint, while FIGARO-DKD prioritized cardiovascular outcomes 1
• The FIDELITY pooled analysis combined both trials (N=13,171) and demonstrated a 14% reduction in composite cardiovascular outcomes (HR 0.86 [95% CI 0.78-0.95]; P = 0.0018) 1

Clinical Significance:

• Together, these trials established finerenone as the first nonsteroidal mineralocorticoid receptor antagonist with proven clinical kidney and cardiovascular benefits 1
• The trials demonstrated benefits across a broad spectrum of CKD severity (eGFR 25-90 mL/min/1.73 m²) 1, 4