To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
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ClinicalTrials.gov Identifier: NCT00518219 |
Recruitment Status :
Completed
First Posted : August 20, 2007
Last Update Posted : May 27, 2010
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Condition or disease | Intervention/treatment | Phase |
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Membranous Nephropathy | Drug: TW | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | To Compare the Efficacy and Safety of TW vs Valsartan in the MN |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: immunosuppressor
TW 120mg/d,Valsartan,160mg/d
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Drug: TW
TW,120mg/d
Other Name: TW,Tripterygium wilfordii Hook.f |
- To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy [ Time Frame: 12 months ]
- To investigate the safety and tolerability of TW vs ARB in treatment of MN [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518219
China, Jiangsu | |
Research Institute of Nephrology | |
Nanjing, Jiangsu, China, 210002 |
Principal Investigator: | Zhihong Liu, Master | Jinling Hospital, China |
Responsible Party: | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00518219 |
Other Study ID Numbers: |
NJCT-0702 |
First Posted: | August 20, 2007 Key Record Dates |
Last Update Posted: | May 27, 2010 |
Last Verified: | March 2009 |
TW Valsartan treatment membranous nephropathy proteinuria |
Kidney Diseases Glomerulonephritis, Membranous Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |