Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial
Joint Authors
Lengnan, Xu
Ban, Zhao
Haitao, Wang
Lili, Liu
Aiqun, Chen
Huan, Wang
Ping, Zeng
Yonghui, Mao
Source
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-06-10
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Background.
Diabetic nephropathy (DN) is a major cause of chronic kidney disease (CKD).
There are no effective treatments to prevent or reverse the progression of DN.
A preliminary study showed that Tripterygium glycosides from Tripterygium wilfordii Hook F (TwHF) with valsartan decrease proteinuria in patients with DN.
Objectives.
The objective of the present study is to investigate the efficacy and safety of Tripterygium glycosides from TwHF, a traditional Chinese medicine, for the treatment of DN.
Methods and Analysis.
This is a prospective, single-center randomized controlled trial.
Seventy participants diagnosed with DN were recruited and randomized 1 : 1 to two groups: (1) angiotensin receptor blocker (ARB) combined with TwHF and (2) ARB-only.
The treatment period is 48 weeks.
The primary endpoint is 24 h proteinuria decreased level (reduction of 30% vs.
baseline) after 48 weeks of treatment.
The secondary endpoints are (1) all-cause and cardiovascular-related mortality, (2) development of ESRD (serum creatinine>530.4 μmol/L or estimated glomerular filtration rate eGFR<15 mL/min/1.73 m2), (3) the need for renal replacement therapy, and (4) increased serum creatinine (2-fold higher than the baseline value or ≥442 μmol/L, with confirmation of the initial results after 4 weeks).
A health economics analysis will be carried out.
Discussion.
A meta-analysis of RCTs carried out in patients with stage 4 (Mogensen classification) diabetic CKD showed that TwHF combined with an ARB was more effective than an ARB alone when considering 24 h proteinuria and serum albumin, but with an increase in adverse event (AE) frequency of 8%.
This is a prospective clinical trial that may provide information on a safe and effective novel method for the treatment of DN, especially for patients with macroproteinuria.
Ethics and Dissemination.
The protocol is approved by the ethics committee of Beijing Hospital (2016BJYYEC-059-02).
The results will be disseminated through peer-reviewed publications and international conferences.
This trial is registered with ChiCTR-IOR-17010623.
American Psychological Association (APA)
Lengnan, Xu& Ban, Zhao& Haitao, Wang& Lili, Liu& Aiqun, Chen& Huan, Wang…[et al.]. 2020. Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial. BioMed Research International،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1138004
Modern Language Association (MLA)
Lengnan, Xu…[et al.]. Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial. BioMed Research International No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1138004
American Medical Association (AMA)
Lengnan, Xu& Ban, Zhao& Haitao, Wang& Lili, Liu& Aiqun, Chen& Huan, Wang…[et al.]. Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial. BioMed Research International. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1138004
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1138004