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

Last updated: August 23, 2024
Sponsor: University Medical Center Groningen
Overall Status: Completed

Phase

3

Condition

Collagen Vascular Diseases

Lupus

Kidney Disease

Treatment

cyclophosphamide

mycophenolate mofetil

Clinical Study ID

NCT00103792
WG-MMF-1
UMCG-ANCA-MMF-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First or second relapse ANCA-associated vasculitis

  • PR3- or MPO-ANCA antibodies present or histological proof of relapse

  • Adult

Exclusion

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 > 100mg/day or prednisolone >25 mg/day

  • Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine

  • Gravidity or inadequate anticonception

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: cyclophosphamide
Phase: 3
Study Start date:
December 01, 2004
Estimated Completion Date:
January 31, 2015

Study 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.

Connect with a study center

  • University Medical Centre Groningen

    Groningen, 9700 RB
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.