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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Hydroxychloroquine | Study protocol

Efficacy and safety of artesunate for patients with IgA nephropathy: a study protocol for a multicenter, double-blind, randomized, placebo-controlled trial

Authors: Qi Chen, Zi Wang, Jicheng Lv, Lijun Liu, Hang Li, Weiwei Sun, Yanhong Huo, Yingbo Guo, Cun Shen, Shichao Li, Zhenjie Chen, Jingwei Zhou

Published in: Trials | Issue 1/2022

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Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

Chinese Clinical Trial Registry ChiCTR2000038104​. Registered on 10 September 2020
Appendix
Available only for authorised users
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Metadata
Title
Efficacy and safety of artesunate for patients with IgA nephropathy: a study protocol for a multicenter, double-blind, randomized, placebo-controlled trial
Authors
Qi Chen
Zi Wang
Jicheng Lv
Lijun Liu
Hang Li
Weiwei Sun
Yanhong Huo
Yingbo Guo
Cun Shen
Shichao Li
Zhenjie Chen
Jingwei Zhou
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06336-3

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