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MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

Primary Purpose

Vasculitis, Anti-Neutrophil Cytoplasmic Antibody

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mycophenolate mofetil
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasculitis focused on measuring ANCA, vasculitis, mycophenolate mofetil, cyclophosphamide, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology. Renal involvement attributable to active ANCA associated vasculitis with at least one of the following: Elevated serum creatinine between 150 and 500 umol/l - renal biopsy Demonstrating paucin -immune necrotizing glomerulonephritis Red cell casts Haematuria with > 30 red blood cells/HPF and proteinuria > 1g/24h Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA Age 18~65 years Exclusion Criteria: More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous 6 months or with oral corticosteroids (OCS) for more than 4 weeks Co-existence of another multisystem autoimmune disease, e.g. SLE Serum creatinine > 500umol/l Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection Congenial or acquired immunodeficiency Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence) Previous malignancy Pregnancy or inadequate contraception if female Anti-GBM antibody positivity Cerebral infarction due to vasculitis Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour Massive gastro-intestinal bleeding Heart failure due to pericarditis or myocarditis Liver dysfunction measured on at least 2 separate occasions Age < 18y or Age > 65y

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mycophenolate mofetil

Arm Description

Outcomes

Primary Outcome Measures

The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2006
Last Updated
June 7, 2010
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00301652
Brief Title
MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
Official Title
Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to access the efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis with renal involvement.
Detailed Description
The ANCA-associated vasculitides can be life threatening. Glucocorticoids and cyclophosphamide therapy is effective in about 80% patients. However, the side effects such as bone marrow suppression, infection, cystitis, infertility, myelodysplasia preclude further use of cyclophosphamide in some patients and the relapse rate is high. Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF), could exhibit multifarious effects on endothelial cells, including inhibition of ICAM-1 expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions. This study was a feasibility study to assess the safety and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared with pulse intravenous cyclophosphamide. After enrollment, subjects were followed longitudinally, and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score (BVAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculitis, Anti-Neutrophil Cytoplasmic Antibody
Keywords
ANCA, vasculitis, 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
Experimental
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Other Intervention Name(s)
MMF,cellcept,mycophenolate mofetil
Intervention Description
MMF,1.0g/d
Primary Outcome Measure Information:
Title
The efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A new diagnosis of ANCA associated vasculitis (eg. MPA or Wegener granulomatous, or renal limited vasculitis) proved by histology and serology. Renal involvement attributable to active ANCA associated vasculitis with at least one of the following: Elevated serum creatinine between 150 and 500 umol/l - renal biopsy Demonstrating paucin -immune necrotizing glomerulonephritis Red cell casts Haematuria with > 30 red blood cells/HPF and proteinuria > 1g/24h Serum ANCA positive by indirect immunofluorescence (IIF) and positivity in the anti-PR3 or anti-MPO by ELISA Age 18~65 years Exclusion Criteria: More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous 6 months or with oral corticosteroids (OCS) for more than 4 weeks Co-existence of another multisystem autoimmune disease, e.g. SLE Serum creatinine > 500umol/l Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection Congenial or acquired immunodeficiency Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence) Previous malignancy Pregnancy or inadequate contraception if female Anti-GBM antibody positivity Cerebral infarction due to vasculitis Rapidly progressive optic neuropathy or retinal vasculitis or orbital pseudotumour Massive gastro-intestinal bleeding Heart failure due to pericarditis or myocarditis Liver dysfunction measured on at least 2 separate occasions Age < 18y or Age > 65y
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei-Shi Li, 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

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MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

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