Overview

MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nanjing University School of Medicine
Treatments:
Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Criteria
Inclusion Criteria:

1. A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or
renal limited vasculitis) proved by histology and serology.

2. 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

3. Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the
anti-PR3 or anti-MPO by ELISA

4. Age 18~65 years

Exclusion Criteria:

1. 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

2. Co-existence of another multisystem autoimmune disease, e.g. SLE

3. Serum creatinine > 500umol/l

4. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known
HIV infection

5. Congenial or acquired immunodeficiency

6. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis
dependence)

7. Previous malignancy

8. Pregnancy or inadequate contraception if female

9. Anti-GBM antibody positivity

10. Cerebral infarction due to vasculitis

11. Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour

12. Massive gastro-intestinal bleeding

13. Heart failure due to pericarditis or myocarditis

14. Liver dysfunction measured on at least 2 separate occasions

15. Age < 18y or Age > 65y