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

Primary Purpose

Membranous Nephropathy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
TW
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Membranous Nephropathy focused on measuring TW, Valsartan, treatment, membranous nephropathy, proteinuria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Institute of Nephrology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immunosuppressor

Arm Description

TW 120mg/d，Valsartan,160mg/d

Outcomes

Primary Outcome Measures

To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy

Secondary Outcome Measures

To investigate the safety and tolerability of TW vs ARB in treatment of MN

Full Information

First Posted
August 16, 2007
Last Updated
May 25, 2010
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00518219
Brief Title
To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
Official Title
To Compare the Efficacy and Safety of TW vs Valsartan in the MN
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Membranous Nephropathy
Keywords
TW, Valsartan, treatment, membranous nephropathy, proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immunosuppressor
Arm Type
Experimental
Arm Description
TW 120mg/d，Valsartan,160mg/d
Intervention Type
Drug
Intervention Name(s)
TW
Other Intervention Name(s)
TW,Tripterygium wilfordii Hook.f
Intervention Description
TW,120mg/d
Primary Outcome Measure Information:
Title
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To investigate the safety and tolerability of TW vs ARB in treatment of MN
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, Master
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Nephrology
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34778952
Citation
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.
Results Reference
derived

Learn more about this trial

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

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