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

February 12, 2009 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: Patricia M. Stassen, M.D., Ph.D.
  • Phone Number: +31433876543
  • Email: p.stassen@mumc.nl

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • Recruiting
        • University Medical Centre Groningen
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Patricia Stassen, M.D. pH.D.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Experimental: 1
mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy
Drug: mycophenolate mofetil
2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
Active Comparator: 2
cyclophosphamide
Drug: cyclophosphamide
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
remission induction rate
Time Frame: 6 months
6 months
disease free survival after 2 and 4 years
Time Frame: 2 and 4 years
2 and 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
time to remission
Time Frame: 9 months
9 months
cumulative organ damage
Time Frame: 4 years
4 years
side-effects
Time Frame: 4 years
4 years
ANCA titres over time
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Coen Stegeman, MD PhD, UMCG Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

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

December 1, 2004

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

February 14, 2005

First Submitted That Met QC Criteria

February 14, 2005

First Posted (Estimate)

February 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WG-MMF-1
  • UMCG-ANCA-MMF-1

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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