Status:
COMPLETED
Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)
Lead Sponsor:
University Medical Center Groningen
Conditions:
Wegener's Granulomatosis
Vasculitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 microsc...
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 ther...
Eligibility Criteria
Inclusion
- First or second relapse ANCA-associated vasculitis
- PR3- or MPO-ANCA antibodies present or histological proof of relapse
- Adult
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00103792
Start Date
December 1 2004
End Date
January 1 2015
Last Update
August 27 2024
Active Locations (1)
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1
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB