MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

Vasculitis Clinical Trial

Official title:

Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301652
• Other study ID #: NJCT-0607
• Status: Completed
• Phase: N/A
• First received: March 10, 2006
• Last updated: June 7, 2010
• Start date: June 2003
• Est. completion date: December 2005

Study information

• Verified date: March 2009
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2005
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anti-Neutrophil Cytoplasmic Antibody
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Intervention

Drug:
• mycophenolate mofetil
MMF,1.0g/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis.		24 months	Yes