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

<b><i>Background:</i></b> 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. <b><i>Patients and</i></b> <b><i>Methods:</i></b> 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. <b><i>Conclusions:</i></b> 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. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.

**背景：** 在糖尿病患者中，合并肾病者的心血管（Cardiovascular, CV）发病率、死亡率以及基础肾病进展的风险均显著升高。非奈利酮（Finerenone）是一种新型非甾体选择性盐皮质激素受体拮抗剂（mineralocorticoid receptor antagonist），已被证实可降低合并慢性肾病（CKD）的2型糖尿病（T2D）患者的白蛋白尿水平，且高钾血症（hyperkalemia）风险较低。然而，目前尚无长期临床试验探究非奈利酮对心血管及肾脏结局的影响。
**患者与方法：** 糖尿病肾病患者中非奈利酮降低心血管死亡率与发病率试验（FIGARO-DKD）旨在评估，相较于安慰剂，非奈利酮在降低合并慢性肾病的2型糖尿病患者的重大心血管及肾脏结局风险方面的有效性与安全性。FIGARO-DKD是一项随机、双盲、安慰剂对照、平行组设计的事件驱动型临床试验，共在47个国家开展，预计持续时长约6年。该试验共纳入7437例患者，其估算肾小球滤过率（estimated glomerular filtration rate）≥25 mL/min/1.73㎡，且存在白蛋白尿（尿白蛋白肌酐比值≥30 mg/g且≤5000 mg/g）。本研究具备至少90%的检验效能，可检测出主要结局风险降低20%的差异（总体双侧显著性水平α=0.05）；主要结局为复合终点，包括首次发生心血管死亡、非致死性心肌梗死、非致死性卒中或心力衰竭住院的时间。
**结论：** FIGARO-DKD试验将明确，在接受最优治疗方案的合并慢性肾病、且心血管与肾脏事件高风险的2型糖尿病患者队列中，加用非奈利酮是否可带来心肾获益。
试验注册：欧盟临床试验数据库（EudraCT）编号：2015-000950-39；美国临床试验数据库（ClinicalTrials.gov）编号：NCT02545049.