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

Primary Purpose

Henoch-Schoenlein Purpura, Nephritis

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mycophenolate mofetil

About this trial

This is an interventional treatment trial for Henoch-Schoenlein Purpura focused on measuring Henoch-Schonlein purpura nephritis Mycophenolate mofetil, Cyclophosphamide, treatment

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Mycophenolate mofetil

Arm Description

Outcomes

Primary Outcome Measures

To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

Secondary Outcome Measures

Full Information

NCT ID

NCT00301613

First Posted

March 10, 2006

Last Updated

May 25, 2010

Sponsor

Nanjing University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00301613

Brief Title

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

Official Title

MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Henoch-Schoenlein Purpura, Nephritis

Keywords

Henoch-Schonlein purpura nephritis Mycophenolate mofetil, Cyclophosphamide, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mycophenolate mofetil

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Mycophenolate mofetil

Other Intervention Name(s)

Mycophenolate mofetil,cellcept

Intervention Description

MMF,1.0g/d

Primary Outcome Measure Information:

Title

To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-Hong Liu, M.D.

Organizational Affiliation

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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