BACKGROUND Persistent proteinuria seems to be a risk factor for progression of renal disease. Its reduction by angiotensin-converting inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) is renoprotective. Our previous pilot study showed that 2-year lisinopril therapy is effective and safe for children with mild IgA nephropathy. When combined with ACEI and ARB, reported results are of greater decrease in proteinuria than monotherapy in chronic glomerulonephritis, including IgA nephropathy. To date, however, there have been no randomized controlled trials in children. METHODS This is an open-label, multicenter, prospective, and randomized phase II controlled trial of 63 children with biopsy-proven proteinuric mild IgA nephropathy. We compared efficacy and safety between patients undergoing lisinopril monotherapy and patients undergoing combination therapy of lisinopril and losartan to determine better treatment for childhood proteinuric mild IgA nephropathy. RESULTS There was no difference in proteinuria disappearance rate (primary endpoint) between the two groups (cumulative disappearance rate of proteinuria at 24 months: 89.3% vs 89% [combination vs monotherapy]). Moreover, there were no significant differences in side effects between the two groups. CONCLUSIONS We propose lisinopril monotherapy as treatment for childhood proteinuric mild IgA nephropathy as there are no advantages of combination therapy. CLINICAL TRIAL REGISTRATION Clinical trial registry, UMIN ID C000000006, https://www.umin.ac.jp .

中文翻译：

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赖诺普利与赖诺普利和氯沙坦治疗儿童轻度IgA肾病：一项随机对照试验（JSKDC01研究）。

背景技术持久性蛋白尿似乎是肾脏疾病进展的危险因素。血管紧张素转换抑制剂（ACEIs）或血管紧张素II受体阻滞剂（ARBs）对其的还原具有肾脏保护作用。我们之前的先期研究表明，2年的赖诺普利治疗对轻度IgA肾病患儿有效且安全。当与ACEI和ARB联合使用时，在包括IgA肾病在内的慢性肾小球肾炎中，与单药治疗相比，蛋白尿的减少幅度更大。然而，迄今为止，还没有针对儿童的随机对照试验。方法这是一项开放性，多中心，前瞻性和随机II期对照试验，对63名经活检证实为蛋白尿性轻度IgA肾病的儿童进行了II期对照试验。我们比较了接受赖诺普利单药治疗的患者和接受赖诺普利和氯沙坦联合治疗的患者之间的疗效和安全性，以确定对儿童蛋白尿轻度IgA肾病的更好治疗方法。结果两组之间的蛋白尿消失率（主要终点）没有差异（24个月时蛋白尿的累积消失率：89.3％vs 89％[联合疗法与单一疗法]）。而且，两组之间的副作用没有显着差异。结论我们建议赖诺普利单药治疗儿童期蛋白尿轻度IgA肾病，因为联合治疗没有优势。临床试验注册临床试验注册，UMIN ID C000000006，https：//www.umin.ac.jp。