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| Sponsored by: |
University Medical Centre Groningen |
| Information provided by: | University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT00103792 |
Purpose
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.
We expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.
| Condition | Intervention | Phase |
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Wegener's Granulomatosis Vasculitis |
Drug: mycophenolate mofetil Drug: cyclophosphamide |
Phase III |
| MedlinePlus related topics: | Vasculitis Wegener's Granulomatosis |
| ChemIDplus related topics: | Cyclophosphamide Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Azathioprine Azathioprine sodium salt |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy
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Drug: mycophenolate mofetil
2000 mg mycophenolate per day combined with steroids for induction remission, followd by azathioprine standard maintenance therapy
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2: Active Comparator
cyclophosphamide
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Drug: cyclophosphamide
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
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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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patricia M. Stassen, M.D. | +31503611295 | p.m.stassen@int.umcg.nl |
| Contact: Coen A. Stegeman, M.D., Ph.D. | +31503616161 | c.a.stegeman@int.umcg.nl |
| Netherlands | |||||
| University Medical Centre Groningen | Recruiting | ||||
| Groningen, Netherlands, 9700 RB | |||||
| Contact: Patricia Stassen, M.D. +31503611295 p.m.stassen@int.umcg.nl | |||||
| Contact: Coen Stegeman, M.D., Ph. D. +31503616161 c.a.stegeman@int.umcg.nl | |||||
| Sub-Investigator: Patricia Stassen, M.D. | |||||
| University Medical Centre Groningen |
| Principal Investigator: | Coen Stegeman, MD PhD | UMCG Groningen |
More Information
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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
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| Responsible Party: | Dept of Nephrology ( University Medical Center Groningen ) |
| Study ID Numbers: | WG-MMF-1, UMCG-ANCA-MMF-1 |
| First Received: | February 14, 2005 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00103792 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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