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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
Sponsor:
Information provided by:
Nanjing University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Membranous Nephropathy Drug: TW Phase 4

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.


Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Valsartan
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: immunosuppressor
TW 120mg/d，Valsartan,160mg/d
 Drug: TW
TW,120mg/d
Other Name: TW,Tripterygium wilfordii Hook.f


Outcome Measures
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Primary Outcome Measures :
  1. To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To investigate the safety and tolerability of TW vs ARB in treatment of MN [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: March 2009

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