title: Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial.
abstract: 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.
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Li
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China.
authors.forename: Yi-Zhi
authors.initials: YZ
authors.lastname: Chen
authors.affiliation: Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China.
authors.forename: Hong-Li
authors.initials: HL
authors.lastname: Lin
authors.affiliation: Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.
authors.forename: Zhao-Hui
authors.initials: ZH
authors.lastname: Ni
authors.affiliation: Department of Nephrology, Guang' anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
authors.forename: Yong-Li
authors.initials: YL
authors.lastname: Zhan
authors.affiliation: Department of Nephrology, Shandong Provincial Hospital, Jinan, 250021, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Wang
authors.affiliation: Department of Nephrology, First Teaching Hospital of Tianjin University of TCM, Tianjin, 300192, China.
authors.forename: Hong-Tao
authors.initials: HT
authors.lastname: Yang
authors.affiliation: Department of Nephrology, The First Hospital of Shanxi Medical University, Taiyuan, 030024, China.
authors.forename: Jing-Ai
authors.initials: JA
authors.lastname: Fang
authors.affiliation: Department of Nephrology, The Sixth Affiliated Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
authors.forename: Nian-Song
authors.initials: NS
authors.lastname: Wang
authors.affiliation: Department of Nephrology, China-Japan Friendship Hospital, Beijing, 100029, China.
authors.forename: Wen-Ge
authors.initials: WG
authors.lastname: Li
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China. xfssun@126.com.|Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Diseases, Fuxing Road 28, Beijing, 100853, People's Republic of China. xfssun@126.com.
authors.forename: Xue-Feng
authors.initials: XF
authors.lastname: Sun
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease, 2011DAV00088, Chinese PLA General Hospital, Beijing, 100853, China. xmchen301@126.com.|Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Diseases, Fuxing Road 28, Beijing, 100853, People's Republic of China. xmchen301@126.com.
authors.forename: Xiang-Mei
authors.initials: XM
authors.lastname: Chen
mesh_terms: D028483:Abelmoschus / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D002985:Clinical Protocols; D004311:Double-Blind Method; D005922:Glomerulonephritis, IGA / Q000188:drug therapy*; D006801:Humans; D019808:Losartan / Q000009:adverse effects / Q000627:therapeutic use*; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D019808:Losartan
keywords: Abelmoschus manihot; IgA nephropathy; Randomized controlled study; Traditional Chinese medicine