NCT00301652

Brief Summary

The purpose of this study is to access the efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis with renal involvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

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

June 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
Last Updated

June 8, 2010

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

March 10, 2006

Last Update Submit

June 7, 2010

Conditions

VasculitisAnti-Neutrophil Cytoplasmic Antibody

Keywords

ANCAvasculitismycophenolate mofetilcyclophosphamidetreatment

Outcome Measures

Primary Outcomes (1)

  • The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis.

    24 months

Study Arms (1)

mycophenolate mofetil

EXPERIMENTAL
Drug: mycophenolate mofetil

Interventions

mycophenolate mofetilDRUG

MMF,1.0g/d

Also known as: MMF,cellcept,mycophenolate mofetil
mycophenolate mofetil

Eligibility Criteria

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

You may qualify if:

  • A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology.
  • Renal involvement attributable to active ANCA associated vasculitis with at least one of the following:
  • Elevated serum creatinine between 150 and 500 umol/l - renal biopsy
  • Demonstrating paucin -immune necrotizing glomerulonephritis
  • Red cell casts
  • Haematuria with \> 30 red blood cells/HPF and proteinuria \> 1g/24h
  • Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA
  • Age 18\~65 years

You may not qualify if:

  • More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous 6 months or with oral corticosteroids (OCS) for more than 4 weeks
  • Co-existence of another multisystem autoimmune disease, e.g. SLE
  • Serum creatinine \> 500umol/l
  • Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
  • Congenial or acquired immunodeficiency
  • Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence)
  • Previous malignancy
  • Pregnancy or inadequate contraception if female
  • Anti-GBM antibody positivity
  • Cerebral infarction due to vasculitis
  • Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour
  • Massive gastro-intestinal bleeding
  • Heart failure due to pericarditis or myocarditis
  • Liver dysfunction measured on at least 2 separate occasions
  • Age \< 18y or Age \> 65y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Vasculitis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Lei-Shi Li, M.D.

    Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 13, 2006

Study Start

June 1, 2003

Primary Completion

April 1, 2004

Study Completion

December 1, 2005

Last Updated

June 8, 2010

Record last verified: 2009-03

Locations

CN(1)