To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
Phase 4
Completed
- Conditions
- Membranous Nephropathy
- Interventions
- Drug: TW
- Registration Number
- NCT00518219
- Lead Sponsor
- Nanjing University School of Medicine
- Brief Summary
The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description immunosuppressor TW TW 120mg/d，Valsartan,160mg/d
- Primary Outcome Measures
Name Time Method To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy 12 months
- Secondary Outcome Measures
Name Time Method To investigate the safety and tolerability of TW vs ARB in treatment of MN 12 months
Trial Locations
- Locations (1)
Research Institute of Nephrology
🇨🇳Nanjing, Jiangsu, China