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

• Status: Unknown status
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Azathioprine; Cyclophosphamide; Mycophenolate mofetil; Mycophenolic Acid

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