To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)

May 25, 2010 updated by: Nanjing University School of Medicine

To Compare the Efficacy and Safety of TW vs Valsartan in the MN

The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immunosuppressor
TW 120mg/d，Valsartan,160mg/d
Drug: TW
TW,120mg/d
Other Names:
  • TW,Tripterygium wilfordii Hook.f

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the safety and tolerability of TW vs ARB in treatment of MN
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Principal Investigator: Zhihong Liu, Master, Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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