Therapeutic Evaluation of Artesunate in IgA Nephropathy (TEATING) Study: A study protocol of a multicenter, double-blind, randomized, placebo-controlled trial

Abstract Background IgA nephropathy is the most common glomerular disease and a common cause of progression to end-stage renal disease in patients with kidney diseases. Proteinuria levels are critical to the prognosis of patients with IgA nephropathy, but many patients are still unable to effectively control proteinuria levels after receiving adequate RAAS blockers. Antimalarial drugs have shown good efficacy in the treatment of kidney disease in previous studies; however, there have been no strict designed randomized controlled trials to confirm the clinical efficacy of artesunate in 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 was a randomized, double-blind, three-group-parallel, placebo-controlled clinical trial. One hundred and twenty eligible IgA nephropathy patients at risk of progression were randomly divided into artesunate 100mg group, artesunate 50 mg group, and placebo group. Changes in proteinuria and renal function were measured after 6 months of intervention. The levels of Gd-IgA1, Anti-Gd-IgA1 in the patient's blood will also be tested to further understand possible immune mechanisms. Discussion Clinical evidence for 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, registration date: 10 September 2020. http://www.chictr.org.cn/edit.aspx?pid=61338&htm=4.