Nephrol Dial Transplant. 2022 Jun 23;37(7):1317-1329. doi: 10.1093/ndt/gfac040.
The effects of the sodium-glucose co-transporter 2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD).
The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily decreases the risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had an estimated glomerular filtration rate (eGFR) ≥20 but <45 mL/min/1.73 m2 or an eGFR ≥45 but <90 mL/min/1.73 m2 with a urinary albumin:creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined, as extra work for collaborating sites is kept to a minimum and only essential information is collected.
Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. The mean age at randomization was 63.8 years [standard deviation (SD) 13.9)], 2192 (33%) were female and 3570 (54%) had no prior history of DM. The mean eGFR was 37.5 mL/min/1.73 m2 (SD 14.8), including 5185 (78%) with an eGFR <45 mL/min/1.73 m2. The median uACR was 412 mg/g) (quartile 1-quartile 3 94-1190), with a uACR <300 mg/g in 3194 (48%). The causes of kidney disease included diabetic kidney disease [n = 2057 (31%)], glomerular disease [n = 1669 (25%)], hypertensive/renovascular disease [n = 1445 (22%)], other [n = 808 (12%)] and unknown causes [n = 630 (10%)].
EMPA-KIDNEY will evaluate the efficacy and safety of empagliflozin in a widely generalizable population of people with CKD at risk of kidney disease progression. Results are anticipated in 2022.
钠-葡萄糖协同转运蛋白 2 抑制剂恩格列净对肾脏和心血管疾病的影响尚未在专门的慢性肾脏病（CKD）人群中进行测试。
EMPA-KIDNEY 试验是一项国际性、随机、双盲、安慰剂对照试验，旨在评估恩格列净 10mg 每日是否降低 CKD 患者的肾脏疾病进展或心血管死亡风险。无论是否患有糖尿病（DM），如果估算肾小球滤过率（eGFR）≥20 但<45mL/min/1.73m2或 eGFR≥45 但<90mL/min/1.73m2，且尿白蛋白与肌酐比值（uACR）≥200mg/g，则符合入组条件。试验设计简化，尽量减少合作站点的额外工作，并仅收集必要信息。
2019 年 5 月 15 日至 2021 年 4 月 16 日，来自欧洲、北美和东亚 8 个国家的 6609 人被随机分组。随机分组时的平均年龄为 63.8 岁[标准差（SD）13.9]，2192 人（33%）为女性，3570 人（54%）无既往 DM 病史。平均 eGFR 为 37.5mL/min/1.73m2（SD 14.8），包括 5185 人（78%）eGFR<45mL/min/1.73m2。中位 uACR 为 412mg/g（四分位距 1-3 分位 94-1190），3194 人（48%）uACR<300mg/g。肾脏疾病的病因包括糖尿病肾病[2057 人（31%）]、肾小球疾病[1669 人（25%）]、高血压/肾血管疾病[1445 人（22%）]、其他[808 人（12%）]和原因不明[630 人（10%）]。
EMPA-KIDNEY 将评估恩格列净在广泛可推广的 CKD 高危人群中的疗效和安全性，预计结果将于 2022 年公布。
