To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
This study has been completed.
Sponsor:
Nanjing University School of Medicine
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00518219
First received: August 16, 2007
Last updated: May 25, 2010
Last verified: March 2009
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Purpose
The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Membranous Nephropathy |
Drug: TW |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | To Compare the Efficacy and Safety of TW vs Valsartan in the MN |
Resource links provided by NLM:
MedlinePlus related topics:
Kidney Diseases
Drug Information available for:
Valsartan
U.S. FDA Resources
Further study details as provided by Nanjing University School of Medicine:
Primary Outcome Measures:
- To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To investigate the safety and tolerability of TW vs ARB in treatment of MN [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 68 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: immunosuppressor
TW 120mg/d，Valsartan,160mg/d
|
Drug: TW
TW,120mg/d
Other Name: TW,Tripterygium wilfordii Hook.f
|
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518219
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518219
Locations
| China, Jiangsu | |
| Research Institute of Nephrology | |
| Nanjing, Jiangsu, China, 210002 | |
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
| Principal Investigator: | Zhihong Liu, Master | Jinling Hospital, China |
More Information
| Responsible Party: | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00518219 History of Changes |
| Other Study ID Numbers: | NJCT-0702 |
| Study First Received: | August 16, 2007 |
| Last Updated: | May 25, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Nanjing University School of Medicine:
|
TW Valsartan treatment membranous nephropathy proteinuria |
Additional relevant MeSH terms:
|
Kidney Diseases Glomerulonephritis, Membranous Urologic Diseases Glomerulonephritis Nephritis Autoimmune Diseases |
Immune System Diseases Valsartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016