Clinical Trial: MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis
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 Summary:
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).
Sponsor: Nanjing University School of Medicine
Current Primary Outcome: The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis. [ Time Frame: 24 months ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Nanjing University School of Medicine
Dates:
Date Received: March 10, 2006
Date Started: June 2003
Date Completion:
Last Updated: June 7, 2010
Last Verified: March 2009
