Department of Nephrology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, No. 5 Haiyuncang, Dongcheng District, Beijing, 100007, China.
Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University and Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, China.
Trials. 2022 May 25;23(1):444. doi: 10.1186/s13063-022-06336-3.
IgA nephropathy is the most common glomerular disease and is a common cause of progression to end-stage renal disease in patients with kidney diseases. Proteinuria levels are critical for the prognosis of patients with IgA nephropathy, but many patients are still unable to effectively control their proteinuria levels after receiving RAAS blockers. Antimalarial drugs have shown good efficacy in the treatment of kidney disease in previous studies; however, there have been no strictly designed randomized controlled trials to confirm the clinical efficacy of artesunate for treating IgA nephropathy patients. Therefore, we designed this clinical trial to compare the effect of artesunate versus placebo in patients with IgA nephropathy.
This study is a randomized, double-blind, three-group-parallel, placebo-controlled clinical trial. One hundred and twenty eligible IgA nephropathy patients at risk of progression will be randomly divided into the artesunate 100-mg group, artesunate 50-mg group, and placebo group. Changes in proteinuria and renal function will be measured 6 months after the intervention. The levels of Gd-IgA1 and anti-Gd-IgA1 in the patient's blood will also be tested to explore the possible immune mechanisms.
Clinical evidence supporting artesunate treatment of IgA nephropathy is currently lacking, and we expect that the results of this trial will provide high-quality clinical evidence for artesunate as a treatment option for IgA nephropathy in the future.
Chinese Clinical Trial Registry ChiCTR2000038104 . Registered on 10 September 2020.
IgA 肾病是最常见的肾小球疾病，也是导致肾脏病患者进展为终末期肾病的常见原因。蛋白尿水平对 IgA 肾病患者的预后至关重要，但许多患者在接受 RAAS 阻滞剂后仍无法有效控制其蛋白尿水平。抗疟药物在以前的研究中已显示出治疗肾脏病的良好疗效；然而，目前还没有严格设计的随机对照试验来证实青蒿琥酯治疗 IgA 肾病患者的临床疗效。因此，我们设计了这项临床试验，以比较青蒿琥酯与安慰剂在 IgA 肾病患者中的疗效。
这是一项随机、双盲、三平行组、安慰剂对照的临床试验。将 120 名有进展风险的符合条件的 IgA 肾病患者随机分为青蒿琥酯 100mg 组、青蒿琥酯 50mg 组和安慰剂组。干预 6 个月后，将测量蛋白尿和肾功能的变化。还将检测患者血液中的 Gd-IgA1 和抗-Gd-IgA1 水平，以探讨可能的免疫机制。
目前缺乏支持青蒿琥酯治疗 IgA 肾病的临床证据，我们期望这项试验的结果将为青蒿琥酯作为 IgA 肾病治疗选择提供高质量的临床证据。
中国临床试验注册中心 ChiCTR2000038104. 注册于 2020 年 9 月 10 日。
