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

May 25, 2010 updated by: Nanjing University School of Medicine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mycophenolate mofetil
Drug: Mycophenolate mofetil
MMF,1.0g/d
Other Names:
  • Mycophenolate mofetil,cellcept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-0605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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