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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.
The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.
| Condition | Intervention | Phase |
|---|---|---|
|
Wegener's Granulomatosis Vasculitis |
Drug: mycophenolate mofetil Drug: cyclophosphamide |
Phase III |
| 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 |
|---|---|
|
1: Experimental
mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy
|
Drug: mycophenolate mofetil
2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
|
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2: Active Comparator
cyclophosphamide
|
Drug: cyclophosphamide
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
|
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., Ph.D. | +31433876543 | p.stassen@mumc.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. pH.D. | |
| Principal Investigator: | Coen Stegeman, MD PhD | UMCG Groningen |
More Information
| Responsible Party: | Dept of Nephrology ( University Medical Center Groningen ) |
| Study ID Numbers: | WG-MMF-1, UMCG-ANCA-MMF-1 |
| Study First Received: | February 14, 2005 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00103792 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Induction therapy ANCA-associated vasculitis Wegener's granulomatosis |
microscopic polyangiitis mycophenolate mofetil cyclophosphamide |
|
Lung Diseases, Interstitial Vasculitis Immunologic Factors Mycophenolic Acid Vascular Diseases Cyclophosphamide Immunosuppressive Agents Microscopic Polyangiitis Anti-Bacterial Agents Azathioprine |
Wegener Granulomatosis Respiratory Tract Diseases Urologic Diseases Lung Diseases Mycophenolate mofetil Wegener's Granulomatosis Antineoplastic Agents, Alkylating Kidney Diseases Antirheumatic Agents Alkylating Agents |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mycophenolic Acid Cyclophosphamide Antibiotics, Antineoplastic Urologic Diseases Respiratory Tract Diseases Therapeutic Uses Mycophenolate mofetil Cardiovascular Diseases Kidney Diseases |
Alkylating Agents Lung Diseases, Interstitial Vasculitis Vascular Diseases Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Wegener Granulomatosis Lung Diseases Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |
