MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
Vasculitis, Anti-Neutrophil Cytoplasmic Antibody
About this trial
This is an interventional treatment trial for Vasculitis focused on measuring ANCA, vasculitis, mycophenolate mofetil, cyclophosphamide, treatment
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Arms of the Study
Arm 1
Experimental
mycophenolate mofetil