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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Abelmoschus manihot – a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Ping Li, Yi-zhi Chen, Hong-li Lin, Zhao-hui Ni, Yong-li Zhan, Rong Wang, Hong-tao Yang, Jing-ai Fang, Nian-song Wang, Wen-ge Li, Xue-feng Sun, Xiang-mei Chen
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-016-1774-6) contains supplementary material, which is available to authorized users.

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

ClinicalTrials.gov, identifier: NCT02231125. Registered on 30 August 2014.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 123 kb)
13063_2016_1774_MOESM1_ESM.doc
Additional file 2: Informed Consent Form. A Multi-center, Double-blind, Double-simulation and Randomized Control Study of Huangkui Capsule for the Treatment of IgA Nephropathy: Informed Consent. (PDF 85 kb)
13063_2016_1774_MOESM2_ESM.pdf
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