Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:12 AM
Study NCT ID:
NCT00729768
Status:
WITHDRAWN
Last Update Posted:
2017-06-22
First Post:
2008-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'C472181', 'term': 'efalizumab'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2008-08-02', 'studyFirstSubmitQcDate': '2008-08-04', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject and renal allograft survival', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Glomerular filtration rate', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Change in glomerular filtration rate', 'timeFrame': '12 weeks to 52 weeks'}, {'measure': 'Transplant renal biopsies', 'timeFrame': '52 weeks'}, {'measure': 'Change in metabolic/cardiovascular risk factors', 'timeFrame': '24 weeks and 52 weeks'}]}, 'conditionsModule': {'keywords': ['Renal transplant', 'Raptiva'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Have signed the informed consent form and the HIPAA patient information form (United States only)\n* Are ≥ 18 years of age\n* Are a transplant recipient of at least one HLA-mismatch kidney\n* For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method\n\nKey Exclusion Criteria:\n\n* Have a history of previous renal transplant\n* Have had a PRA \\> 25% at any time\n* Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ\n* Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum\n* Have had previous treatment with efalizumab\n* Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer\n* Have a known contraindication to efalizumab\n* Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies\n* Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab\n* Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate'}, 'identificationModule': {'nctId': 'NCT00729768', 'briefTitle': 'A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation', 'orgStudyIdInfo': {'id': 'ACD4230g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: basiliximab', 'Drug: efalizumab', 'Drug: mycophenolate mofetil', 'Drug: corticosteroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: basiliximab', 'Drug: mycophenolate mofetil', 'Drug: corticosteroids', 'Drug: cyclosporine']}], 'interventions': [{'name': 'basiliximab', 'type': 'DRUG', 'description': '2 intravenous doses', 'armGroupLabels': ['1', '2']}, {'name': 'efalizumab', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['1']}, {'name': 'mycophenolate mofetil', 'type': 'DRUG', 'description': 'Oral repeating dose', 'armGroupLabels': ['1', '2']}, {'name': 'corticosteroids', 'type': 'DRUG', 'description': 'Repeating doses', 'armGroupLabels': ['1', '2']}, {'name': 'cyclosporine', 'type': 'DRUG', 'description': 'Oral repeating dose', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}