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

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00301613
First received: March 10, 2006
Last updated: May 25, 2010
Last verified: July 2008
History of Changes

March 10, 2006
May 25, 2010
January 2003
May 2005   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00301613 on ClinicalTrials.gov Archive Site
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Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN
MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Henoch-Schoenlein Purpura
  • Nephritis
Drug: Mycophenolate mofetil
MMF,1.0g/d
Other Name: Mycophenolate mofetil,cellcept
Active Comparator: Mycophenolate mofetil
Intervention: Drug: Mycophenolate mofetil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2006
May 2005   (final data collection date for primary outcome measure)

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
Both
16 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00301613
NJCT-0605
Yes
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
Nanjing University School of Medicine
Not Provided
Study Chair: Zhi-Hong Liu, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing University School of Medicine
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP