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Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)

Primary Purpose

Wegener's Granulomatosis, Vasculitis

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
mycophenolate mofetil
cyclophosphamide
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wegener's Granulomatosis focused on measuring Induction therapy, ANCA-associated vasculitis, Wegener's granulomatosis, microscopic polyangiitis, mycophenolate mofetil, cyclophosphamide

Eligibility Criteria

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

Inclusion Criteria: First or second relapse ANCA-associated vasculitis PR3- or MPO-ANCA antibodies present or histological proof of relapse Adult Exclusion Criteria: Severe alveolar bleeding or (imminent) respiratory failure Renal failure (serum creatinine >500 umol/L or dialysis) Maintenance therapy before start of study consisting of: cyclophosphamide > 100 mg/day or prednisolone >25 mg/day Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine Gravidity or inadequate anticonception

Sites / Locations

  • University Medical Centre GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy

cyclophosphamide

Outcomes

Primary Outcome Measures

remission induction rate
disease free survival after 2 and 4 years

Secondary Outcome Measures

time to remission
cumulative organ damage
side-effects
ANCA titres over time

Full Information

First Posted
February 14, 2005
Last Updated
February 12, 2009
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT00103792
Brief Title
Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)
Official Title
Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil. The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.
Detailed Description
Treatment of ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. The standard induction therapy of a relapse of Wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. Although this induction therapy is very effective, it is very toxic as well. Searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. We will compare the effect and safety of the standard induction therapy with the new therapy. When relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wegener's Granulomatosis, Vasculitis
Keywords
Induction therapy, ANCA-associated vasculitis, Wegener's granulomatosis, microscopic polyangiitis, mycophenolate mofetil, cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Description
2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
Primary Outcome Measure Information:
Title
remission induction rate
Time Frame
6 months
Title
disease free survival after 2 and 4 years
Time Frame
2 and 4 years
Secondary Outcome Measure Information:
Title
time to remission
Time Frame
9 months
Title
cumulative organ damage
Time Frame
4 years
Title
side-effects
Time Frame
4 years
Title
ANCA titres over time
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First or second relapse ANCA-associated vasculitis PR3- or MPO-ANCA antibodies present or histological proof of relapse Adult Exclusion Criteria: Severe alveolar bleeding or (imminent) respiratory failure Renal failure (serum creatinine >500 umol/L or dialysis) Maintenance therapy before start of study consisting of: cyclophosphamide > 100 mg/day or prednisolone >25 mg/day Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine Gravidity or inadequate anticonception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia M. Stassen, M.D., Ph.D.
Phone
+31433876543
Email
p.stassen@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Coen A. Stegeman, M.D., Ph.D.
Phone
+31503616161
Email
c.a.stegeman@int.umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coen Stegeman, MD PhD
Organizational Affiliation
UMCG Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Stassen, M.D.
Phone
+31503611295
Email
p.m.stassen@int.umcg.nl
First Name & Middle Initial & Last Name & Degree
Coen Stegeman, M.D., Ph. D.
Phone
+31503616161
Email
c.a.stegeman@int.umcg.nl
First Name & Middle Initial & Last Name & Degree
Patricia Stassen, M.D. pH.D.

12. IPD Sharing Statement

Citations:
Citation
Stegeman CA; Cohen Tervaert JW. Mycophenolate mofetil for remission induction in patients with active Wegener's Granulomatosis (WG) intolerant for cyclophosphamide. J Am Soc Nephrol(11):98A, 2000
Results Reference
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Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)

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