Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Jun 10:2020:9181037.
doi: 10.1155/2020/9181037. eCollection 2020.

Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial

Xu Lengnan  1 , Zhao Ban  1 , Wang Haitao  1 , Liu Lili  1 , Chen Aiqun  1 , Wang Huan  1 , Zeng Ping  2 , Mao Yonghui  1
Affiliations
Randomized Controlled Trial

Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial

Xu Lengnan et al. Biomed Res Int. .

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

All authors have completed the International Committee of Medical Journal Editors (ICMJE) uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare no support for the submitted work from any organization, no financial relationships with any organization that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1
Stratified randomization method. DN: diabetic nephropathy; ARB: angiotensin receptor blocker; TwHF: Tripterygium wilfordii Hook F.
Figure 2
Figure 2
Study process. aCompared with baseline. DN: diabetic nephropathy; ARB: angiotensin receptor blocker; TwHF: Tripterygium wilfordii Hook F.
See this image and copyright information in PMC

References

    1. Introduction:Standards of Medical Care in Diabetes-2019. Diabetes Care. 2018;42(Supplement 1):S1–S2. doi: 10.2337/dc19-Sint01. - DOI - PubMed
    1. de Boer I. H., Rue T. C., Hall Y. N., Heagerty P. J., Weiss N. S., Himmelfarb J. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011;305(24):2532–2539. doi: 10.1001/jama.2011.861. - DOI - PMC - PubMed
    1. Bakris G. L. Recognition, pathogenesis, and treatment of different stages of nephropathy in patients with type 2 diabetes mellitus. Mayo Clinic Proceedings. 2011;86(5):444–456. doi: 10.4065/mcp.2010.0713. - DOI - PMC - PubMed
    1. Saran R., Robinson B., Abbott K. C., et al. US renal data system 2018 annual data report: epidemiology of kidney disease in the United States. Am J Kidney Dis. 2019;73(3):A7–A8. doi: 10.1053/j.ajkd.2019.01.001. - DOI - PMC - PubMed
    1. Ma R. C. W. Epidemiology of diabetes and diabetic complications in China. Diabetologia. 2018;61(6):1249–1260. doi: 10.1007/s00125-018-4557-7. - DOI - PubMed

Publication types

Substances