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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: | NCT00301613 |
This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN
Condition | Intervention |
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Henoch-Schoenlein Purpura Nephritis |
Drug: Mycophenolate mofetil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis |
Enrollment: | 60 |
Study Start Date: | January 2003 |
Study Completion Date: | January 2006 |
Primary Completion Date: | May 2005 (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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Henoch-Schoenlein purpura nephritis (HSPN) with massive proteinuria,renal insufficiency and crescent formation at onset have high risks of progressing to end stage renal failure. Though clinical studies have shown that steroids in combination with cyclophosphamide could reduce proteinuria and preserve renal function, this protocol is associated with many side effects, and is not effective in some patients.
Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF),could inhibit multifarious effects on endothelial cells, including adhesion molecular expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitis. Clinical studies also showed that MMF was effective in the treatment of lupus nephritis with vasculitic lesions. These findings suggest that MMF might be effective in the treatment of severe HSPN, which is a kind of vasculitic lesion. This prospective open-labeled clinical trial study investigates the efficiency of MMF in the treatment of severe HSPN compared with pulse intravenous cyclophosphamide. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of MMF compared with cyclophosphamide in the treatment of severe HSPN.
Ages Eligible for Study: | 16 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
China, Jiangsu | |
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | |
Nanjing, Jiangsu, China, 210002 |
Study Chair: | Zhi-Hong Liu, 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-0605 |
Study First Received: | March 10, 2006 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00301613 |
Health Authority: | China: State Food and Drug Administration |
Henoch-Schonlein purpura nephritis Mycophenolate mofetil Cyclophosphamide treatment |
Purpura Vasculitis Hematologic Diseases Purpura, Schoenlein-Henoch Blood Coagulation Disorders Mycophenolic Acid Vascular Diseases Vasculitis, Hypersensitivity Cyclophosphamide |
Hemostatic Disorders Signs and Symptoms Hypersensitivity Hemorrhagic Disorders Urologic Diseases Nephritis Mycophenolate mofetil Kidney Diseases Henoch-Schonlein purpura |
Skin Manifestations Immune Complex Diseases Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases |