drugset / Trial / NCT00103792

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

NCT00103792

Phase 3 Completed 84 enrolled University Medical Center Groningen
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-12
Primary completion
2014-12
Completion
2015-01

Publications

  • Background 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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 2 mg/kg
Subject Mycophenolate Mofetil Small molecule 2000 mg