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Sponsored by: |
Nanjing University School of Medicine |
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Information provided by: | Nanjing University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00301652 |
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.
Condition | Intervention |
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Vasculitis Anti-Neutrophil Cytoplasmic Antibody |
Drug: mycophenolate mofetil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis |
Enrollment: | 60 |
Study Start Date: | June 2003 |
Study Completion Date: | December 2005 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: mycophenolate mofetil
MMF,1.0g/d
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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 enrolment, subjects were followed longitudinally, and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score (BVAS).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Renal involvement attributable to active ANCA associated vasculitis with at least one of the following:
Exclusion Criteria:
China, Jiangsu | |
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 |
Responsible Party: | Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine ) |
Study ID Numbers: | NJCT-0607 |
Study First Received: | March 10, 2006 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00301652 |
Health Authority: | China: State Food and Drug Administration |
ANCA vasculitis mycophenolate mofetil cyclophosphamide treatment |
Antibodies, Antineutrophil Cytoplasmic Antibodies Vasculitis Mycophenolic Acid |
Mycophenolate mofetil Vascular Diseases Cyclophosphamide Immunoglobulins |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |