Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain,
CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain,
Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.
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.
在患有糖尿病的人群中，患有肾脏疾病的患者心血管（CV）发病率和死亡率以及潜在肾脏疾病的进展率极高。非奈利酮是一种新型的、非甾体类、选择性盐皮质激素受体拮抗剂，已显示可降低 2 型糖尿病（T2D）合并慢性肾脏病（CKD）患者的蛋白尿，同时仅显示出低钾血症的低风险。然而，非奈利酮在长期试验中对 CV 和肾脏结局的影响尚未得到研究。
非奈利酮在降低糖尿病肾病中的心血管死亡率和发病率（FIGARO-DKD）试验旨在评估与安慰剂相比，非奈利酮在降低 T2D 合并 CKD 患者临床重要 CV 和肾脏结局方面的疗效和安全性。FIGARO-DKD 是一项在 47 个国家进行的随机、双盲、安慰剂对照、平行组、事件驱动的试验，预计持续约 6 年。FIGARO-DKD 将 7437 名估计肾小球滤过率≥25mL/min/1.73m2 且蛋白尿（尿白蛋白与肌酐比值≥30 至≤5000mg/g）的患者随机分组。该研究有至少 90%的把握度可检测出主要结局（整体双侧显著性水平α=0.05）风险降低 20%，该结局为 CV 死亡、非致死性心肌梗死、非致死性卒中和心力衰竭住院的首次发生时间的复合终点。
FIGARO-DKD 将确定在 CV 和肾脏事件风险高的 CKD 合并 T2D 患者中，将非奈利酮加入其治疗方案是否会带来心脏肾脏获益。
EudraCT 编号：2015-000950-39；ClinicalTrials.gov 标识符：NCT02545049。
