Status:
COMPLETED
MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody
Eligibility:
All Genders
18-65 years
Phase:
NA
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.
Detailed Description
The ANCA-associated vasculitides can be life threatening. Glucocorticoids and cyclophosphamide therapy is effective in about 80% patients. However, the side effects such as bone marrow suppression, in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00301652
Start Date
June 1 2003
End Date
December 1 2005
Last Update
June 8 2010
Active Locations (1)
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1
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002