Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-26 @ 8:44 AM
Study NCT ID:
NCT00103792
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2005-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D055953', 'term': 'Microscopic Polyangiitis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2005-02-14', 'studyFirstSubmitQcDate': '2005-02-14', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission induction rate', 'timeFrame': '6 months'}, {'measure': 'disease free survival after 2 and 4 years', 'timeFrame': '2 and 4 years'}], 'secondaryOutcomes': [{'measure': 'time to remission', 'timeFrame': '9 months'}, {'measure': 'cumulative organ damage', 'timeFrame': '4 years'}, {'measure': 'side-effects', 'timeFrame': '4 years'}, {'measure': 'ANCA titres over time', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Induction therapy', 'ANCA-associated vasculitis', "Wegener's granulomatosis", 'microscopic polyangiitis', 'mycophenolate mofetil', 'cyclophosphamide'], 'conditions': ["Wegener's Granulomatosis", 'Vasculitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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"}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.", 'detailedDescription': "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.\n\nSearching 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First or second relapse ANCA-associated vasculitis\n* PR3- or MPO-ANCA antibodies present or histological proof of relapse\n* Adult\n\nExclusion Criteria:\n\n* Severe alveolar bleeding or (imminent) respiratory failure\n* Renal failure (serum creatinine \\>500 umol/L or dialysis)\n* Maintenance therapy before start of study consisting of: cyclophosphamide \\> 100 mg/day or prednisolone \\>25 mg/day\n* Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine\n* Gravidity or inadequate anticonception'}, 'identificationModule': {'nctId': 'NCT00103792', 'briefTitle': "Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)", 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'WG-MMF-1'}, 'secondaryIdInfos': [{'id': 'UMCG-ANCA-MMF-1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 MMF induction', 'description': 'mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy', 'interventionNames': ['Drug: mycophenolate mofetil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 CYC induction', 'description': 'cyclophosphamide and steroids, followed by maintenance therapy (azathioprine)', 'interventionNames': ['Drug: cyclophosphamide']}], 'interventions': [{'name': 'mycophenolate mofetil', 'type': 'DRUG', 'description': '2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy', 'armGroupLabels': ['1 MMF induction']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': '2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy', 'armGroupLabels': ['2 CYC induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Coen Stegeman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMCG Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}