MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis|
- The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||December 2005|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
|Experimental: mycophenolate mofetil||
Drug: mycophenolate mofetil
Other Name: MMF,cellcept,mycophenolate mofetil
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301652
|Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine|
|Nanjing, Jiangsu, China, 210002|
|Study Chair:||Lei-Shi Li, M.D.||Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine|