To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
Information source: Nanjing University School of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Membranous Nephropathy
Intervention: Valsartan (Drug); TW (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nanjing University School of Medicine Official(s) and/or principal investigator(s):
Zhihong Liu, Master, Principal Investigator, Affiliation: Jinling Hospital, China
Overall contact:
Zhihong Liu, Master, Phone: 0086-025-80860218
Summary
The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment
of heavy proteinuria of membranous nephropathy.
Clinical Details
Official title: To Compare the Efficacy and Safety of TW vs Valsartan in the MN
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy
Secondary outcome: To investigate the safety and tolerability of TW vs ARB in treatment of MN
Detailed description:
Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.
Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of
chronic glomerular nephritis,such as IgA nephropathy. So, we designed this randomized,
prospective clinical trial to assess the efficacy and safety of TW versus Valsartan in the
treatment of heavy proteinuria of MN.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria (> 4 g/day) and serum albumin < 30 g/dl
- Age over 18 with informed consent
Exclusion Criteria:
- Patient with abnormal liver function tests
- Prior therapy with sirolimus, CSA, MMF, tacrolimus or azathioprin, chlorambucil,
levamisole, methotrexate, or nitrogen mustard in the last 90 days,
- Active/serious infection,
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
Locations and Contacts
Zhihong Liu, Master, Phone: 0086-025-80860218
Research Institute of Nephrology, Nanjing, Jiangsu 210002, China; Recruiting
Shijun Li, M.D., Phone: 0086-025-80860469, Email: lsj8855@yahoo.com.cn
Zhihong Liu, Master, Principal Investigator
Additional Information
Starting date: July 2007
Ending date: September 2009
Last updated: March 16, 2009
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