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

NCT ID: NCT00518219

Last Updated: 2010-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immunosuppressor

TW 120mg/d,Valsartan,160mg/d

Group Type EXPERIMENTAL

TW

Intervention Type DRUG

TW,120mg/d

Interventions

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TW

TW,120mg/d

Intervention Type DRUG

Other Intervention Names

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TW,Tripterygium wilfordii Hook.f

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Nanjing University School of Medicine

Principal Investigators

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Zhihong Liu, Master

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital, China

Locations

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Research Institute of Nephrology

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

Reference Type DERIVED
PMID: 34778952 (View on PubMed)

Other Identifiers

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NJCT-0702

Identifier Type: -

Identifier Source: org_study_id

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