Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial.
Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-016-1774-6
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发表时间：
2017-04-11
期刊：
影响因子：
2.5
通讯作者：
Chen XM
中科院分区：
文献类型：
--
作者：
Li P;Chen YZ;Lin HL;Ni ZH;Zhan YL;Wang R;Yang HT;Fang JA;Wang NS;Li WG;Sun XF;Chen XM
IgA 肾病 (IgAN) 是世界范围内最常见的原发性肾小球疾病之一，但有效的治疗方法仍然有限，许多患者进展为终末期肾病 (ESRD)。根据 2012 年肾脏病：改善全球结局 (KDIGO) 指南，只有血管紧张素转换酶抑制剂 (ACE-I)/血管紧张素受体阻滞剂 (ARB) 显示出高水平证据（1B 级）对 IgAN 治疗有价值。然而，中医药在肾脏疾病研究中引起了人们的关注。根据我们已完成的随机对照临床试验，黄蜀葵作为中药单药对原发性肾小球疾病具有治疗作用。在这里，我们进行了一项新研究来评估黄秋葵治疗 IgAN 的功效和安全性。此外，这项研究也是目前规模最大的治疗 IgAN 的双盲、随机对照注册临床研究。我们将进行一项多中心、前瞻性、双盲、双模拟随机对照研究。该研究被设计为非劣效性临床试验。中国100个中心将招募约1600名经活检证实的IgAN患者，并进行长达48周的随访。 IgAN 患者将被随机分为黄葵组（黄葵胶囊，2.5 g，每天 3 次）和氯沙坦钾组（氯沙坦钾，100 mg/d）。主要结局是治疗 48 周后 24 小时蛋白尿相对于基线的变化。治疗 48 周后估计肾小球滤过率 (eGFR) 相对于基线的变化、终点事件的发生率（蛋白尿≥3.5 g/24 小时、血清肌酐加倍或接受血液净化治疗）是次要结局。在第 0、4、12、24、36 和 48 周时测量 24 小时蛋白尿和 eGFR。这项研究将有足够的规模和范围来评估黄蜀葵与氯沙坦钾治疗 IgAN 患者的疗效和安全性。本研究结果可能为IgAN提供新的、有效的、安全的治疗策略。 ClinicalTrials.gov，标识符：NCT02231125。注册于 2014 年 8 月 30 日。本文的在线版本 (doi:10.1186/s13063-016-1774-6) 包含补充材料，可供授权用户使用。
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN. We will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks. This study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN. ClinicalTrials.gov, identifier: NCT02231125. Registered on 30 August 2014. The online version of this article (doi:10.1186/s13063-016-1774-6) contains supplementary material, which is available to authorized users.