Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial

• Published in: American journal of nephrology Vol. 50; no. 5; p. 345
• Main Authors: Ruilope, Luis M, Agarwal, Rajiv, Anker, Stefan D, Bakris, George L, Filippatos, Gerasimos, Nowack, Christina, Kolkhof, Peter, Joseph, Amer, Mentenich, Nicole, Pitt, Bertram
• Format: Journal Article
• Language: English
• Published: Switzerland 2019
• Subjects: Aged; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - etiology; Cardiovascular Diseases - prevention & control; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - mortality; Diabetes Mellitus, Type 2 - urine; Diabetic Nephropathies - complications; Diabetic Nephropathies - drug therapy; Diabetic Nephropathies - mortality; Diabetic Nephropathies - urine; Disease Progression; Double-Blind Method; Female; Follow-Up Studies; Glomerular Filtration Rate; Humans; Male; Middle Aged; Mineralocorticoid Receptor Antagonists - therapeutic use; Naphthyridines - therapeutic use; Renal Insufficiency, Chronic - drug therapy; Renal Insufficiency, Chronic - etiology; Renal Insufficiency, Chronic - mortality; Research Design; Treatment Outcome; Clinical; Diabetes; Aldosterone; Mineralocorticoid; Kidney; Outcomes
• ISSN: 1421-9670
• DOI: 10.1159/000503712

Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials.
The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m2 and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.
EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.