Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00135967
Status:
COMPLETED
Last Update Posted:
2005-12-06
First Post:
2005-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mycophenolate Mofetil in Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'lastUpdateSubmitDate': '2005-12-05', 'studyFirstSubmitDate': '2005-08-25', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2005-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal function (serum creatinine)'}, {'measure': 'proteinuria'}], 'secondaryOutcomes': [{'measure': 'side effects'}, {'measure': 'relapse rate'}]}, 'conditionsModule': {'keywords': ['membranous nephropathy', 'mycophenolate mofetil', 'cyclophosphamide', 'prednisone'], 'conditions': ['Glomerulonephritis, Membranous']}, 'referencesModule': {'references': [{'pmid': '17660026', 'type': 'DERIVED', 'citation': 'Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.'}]}, 'descriptionModule': {'briefSummary': 'Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.\n\nIn this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Membranous nephropathy\n* Serum creatinine (Screat)\\> 1,5 mg/dl or ECC \\< 70 ml/min or increase Screat \\> 50%\n* Proteinuria \\> 2 g/day\n\nExclusion Criteria:\n\n* Systemic diseases\n* Pregnancy wish\n* Active infection\n* Liver dysfunction\n* Abnormal hematology lab\n* Unstable angina\n* Nonsteroidal anti-inflammatory agents (NSAIDs)'}, 'identificationModule': {'nctId': 'NCT00135967', 'briefTitle': 'Mycophenolate Mofetil in Membranous Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study', 'orgStudyIdInfo': {'id': 'RUNMN02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mycophenolate mofetil orally 1000 mg twice a day (BID)', 'type': 'DRUG'}, {'name': 'prednisone 0,5 mg/kg orally on alternate days', 'type': 'DRUG'}, {'name': 'intravenous (i.v.) methylprednisolone 1000 mg, total 9', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Department of Nephrology Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Jack F Wetzels, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}]}}}