MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

NCT ID: NCT00301652

Last Updated: 2010-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-12-31

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, infection, cystitis, infertility, myelodysplasia preclude further use of cyclophosphamide in some patients and the relapse rate is high.

Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF), could exhibit multifarious effects on endothelial cells, including inhibition of ICAM-1 expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions. This study was a feasibility study to assess the safety and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared with pulse intravenous cyclophosphamide. After enrollment, subjects were followed longitudinally, and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score (BVAS).

Conditions

Vasculitis; Anti-Neutrophil Cytoplasmic Antibody

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mycophenolate mofetil

Group Type: EXPERIMENTAL

mycophenolate mofetil

Intervention Type: DRUG

MMF,1.0g/d

Interventions

mycophenolate mofetil

MMF,1.0g/d

Intervention Type: DRUG

Other Intervention Names

MMF,cellcept,mycophenolate mofetil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Nanjing University School of Medicine

Principal Investigators

Lei-Shi Li, M.D.

Role: STUDY_CHAIR

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

Locations

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

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NJCT-0607

Identifier Type: -

Identifier Source: org_study_id