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Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN

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ClinicalTrials.gov Identifier: NCT00301613
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
Nanjing University School of Medicine

Study Description
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Brief Summary:
This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

Condition or disease Intervention/treatment Phase
Henoch-Schoenlein Purpura Nephritis Drug: Mycophenolate mofetil Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis
Study Start Date : January 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mycophenolate mofetil Drug: Mycophenolate mofetil
MMF,1.0g/d
Other Name: Mycophenolate mofetil,cellcept


Outcome Measures
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Primary Outcome Measures :
  1. To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 16-50 years
  • Biopsy proved HSP
  • Proteinuria ≥ 3.0 g/24hr
  • Scr < 5.0 mg/dl

Exclusion Criteria:

  • Cytotoxic drug treatment such as CTX, CsA, MMF for morn than 1 month-3 months prior to enrolled
  • Pregnancy
  • Active/serious infections
  • Previous diagnosed diabetes mellitus type 1 or 2
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301613


Locations
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China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
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Study Chair: Zhi-Hong Liu, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
More Information
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Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00301613    
Other Study ID Numbers: NJCT-0605
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: July 2008
Keywords provided by Nanjing University School of Medicine:
Henoch-Schonlein purpura nephritis Mycophenolate mofetil
Cyclophosphamide
treatment
Additional relevant MeSH terms:
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Nephritis
Purpura, Schoenlein-Henoch
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Kidney Diseases
Urologic Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
 Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action