NCT00518219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 27, 2010

Status Verified

March 1, 2009

Enrollment Period

1.7 years

First QC Date

August 16, 2007

Last Update Submit

May 25, 2010

Conditions

Membranous Nephropathy

Keywords

TWValsartantreatmentmembranous nephropathyproteinuria

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (1)

immunosuppressor

EXPERIMENTAL

TW 120mg/d，Valsartan,160mg/d

Drug: TW

Interventions

TWDRUG

TW,120mg/d

Also known as: TW,Tripterygium wilfordii Hook.f
immunosuppressor

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-proven idiopathic membranous nephropathy
  • Nephrotic syndrome with proteinuria (\> 4 g/day) and serum albumin \< 30 g/dl
  • Age over 18 with informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Nephrology

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

  • 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.

    PMID: 34778952DERIVED

MeSH Terms

Conditions

Glomerulonephritis, MembranousProteinuria

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zhihong Liu, Master

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

May 27, 2010

Record last verified: 2009-03

Locations

CN(1)