UNASSIGNED: Patients with an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) 200-5,000 mg/g were randomized to dapagliflozin 10 mg once daily or placebo, along with standard-of-care and followed for median 2.4 years. The primary endpoint was a composite of ≥50% sustained decline in eGFR, ESKD, or kidney or cardiovascular death. Exploratory efficacy endpoints included eGFR slope and UACR.
UNASSIGNED: Among DAPA-CKD participants with membranous nephropathy, 19 were randomized to dapagliflozin and 24 to placebo. The mean (SD) age was 59.9 ± 12.1 years, the mean eGFR was 45.7 ± 12.1 mL/min/1.73 m2, and the median UACR was 1,694.5 (25%, 75% range 891-2,582.5) mg/g. Two of 19 (11%) patients randomized to dapagliflozin and five of 24 (21%) randomized to placebo experienced the primary composite endpoint. Total and chronic mean eGFR slopes for dapagliflozin and placebo were -3.87 and -4.29 and -2.66 and -4.22 mL/min/1.73 m2/year, respectively; corresponding between-group mean differences were 0.42 and 1.57 mL/min/1.73 m2/year. Dapagliflozin reduced geometric mean (SEM) UACR relative to placebo (-29.3% ± 1.2% vs. -3.6% ± 1.1%; between-group mean difference [95% CI] -26.7 [-50.4, 8.3]). Four (21%) patients randomized to dapagliflozin and seven (29%) randomized to placebo experienced a serious adverse event.
UNASSIGNED: In membranous nephropathy, the effects of dapagliflozin on kidney disease progression and albuminuria were generally favorable; there was insufficient power to justify formal inference testing.
■估计肾小球滤过率(eGFR)为25-75mL/min/1.73m2且尿白蛋白与肌酐之比(UACR)为200-5,000mg/g的患者随机分为达格列净10mg,每日一次或安慰剂,以及标准治疗,并随访中位数2.4年。主要终点是eGFR持续下降≥50%,ESKD,或肾脏或心血管死亡。探索性疗效终点包括eGFR斜率和UACR。
■在患有膜性肾病的DAPA-CKD参与者中,19人被随机分配给达格列净,24人被随机分配给安慰剂。平均(SD)年龄为59.9±12.1岁,平均eGFR为45.7±12.1mL/min/1.73m2,中位数UACR为1,694.5(25%,75%范围891-2,582.5)mg/g。19名患者中有2名(11%)随机接受达格列净治疗,24名患者中有5名(21%)随机接受安慰剂治疗。达格列净和安慰剂的总和慢性平均eGFR斜率分别为-3.87和-4.29和-2.66和-4.22mL/min/1.73m2/年,相应的组间平均差异分别为0.42和1.57mL/min/1.73m2/年。Dapagliflozin相对于安慰剂降低了几何平均值(SEM)UACR(-29.3%±1.2%vs.-3.6%±1.1%;组间平均差[95%CI]-26.7[-50.4,8.3])。4名(21%)随机接受达格列净治疗的患者和7名(29%)随机接受安慰剂治疗的患者经历了严重不良事件。
■在膜性肾病中,达格列净对肾脏疾病进展和白蛋白尿的影响总体上是有利的;没有足够的力量证明正式的推断测试是合理的.