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Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN
This study has been completed.
Sponsored by: Nanjing University School of Medicine
Information provided by: Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00301613
  Purpose

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


Condition Intervention
Henoch-Schoenlein Purpura
Nephritis
Drug: Mycophenolate mofetil

Genetics Home Reference related topics: hemophilia
Drug Information available for: Cyclophosphamide Mycophenolate Mofetil Mycophenolate mofetil hydrochloride
U.S. FDA Resources
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

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
A: Experimental Drug: Mycophenolate mofetil
MMF,1.0g/d

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301613

Locations
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
Study Chair: Zhi-Hong Liu, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  More Information

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

Keywords provided by Nanjing University School of Medicine:
Henoch-Schonlein purpura nephritis Mycophenolate mofetil
Cyclophosphamide
treatment

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009