Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT00228020
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2005-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D013256', 'term': 'Steroids'}], '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': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first BPAR episode or treatment failure', 'timeFrame': '6 months', 'description': 'Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).'}]}, 'conditionsModule': {'keywords': ['pediatric, kidney transplantation, basiliximab'], 'conditions': ['Pediatric Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '19005406', 'type': 'DERIVED', 'citation': 'Offner G, Toenshoff B, Hocker B, Krauss M, Bulla M, Cochat P, Fehrenbach H, Fischer W, Foulard M, Hoppe B, Hoyer PF, Jungraithmayr TC, Klaus G, Latta K, Leichter H, Mihatsch MJ, Misselwitz J, Montoya C, Muller-Wiefel DE, Neuhaus TJ, Pape L, Querfeld U, Plank C, Schwarke D, Wygoda S, Zimmerhackl LB. Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids. Transplantation. 2008 Nov 15;86(9):1241-8. doi: 10.1097/TP.0b013e318188af15.'}, {'pmid': '19005405', 'type': 'DERIVED', 'citation': 'Hocker B, Kovarik JM, Daniel V, Opelz G, Fehrenbach H, Holder M, Hoppe B, Hoyer P, Jungraithmayr TC, Kopf-Shakib S, Laube GF, Muller-Wiefel DE, Offner G, Plank C, Schroder M, Weber LT, Zimmerhackl LB, Tonshoff B. Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. Transplantation. 2008 Nov 15;86(9):1234-40. doi: 10.1097/TP.0b013e318188ae18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are recipients of primary or secondary renal allograft.\n* Patients who are single-organ recipients (kidney only).\n\nExclusion Criteria:\n\n•Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00228020', 'briefTitle': 'Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients', 'orgStudyIdInfo': {'id': 'CCHI621ADE01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basiliximab', 'description': 'Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids', 'interventionNames': ['Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Basiliximab-free', 'description': 'Patients will be on a regimen of MMF, cyclosporine and steroids.', 'interventionNames': ['Drug: MMF, cyclosporine, steroids']}], 'interventions': [{'name': 'basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)', 'type': 'DRUG', 'armGroupLabels': ['Basiliximab']}, {'name': 'MMF, cyclosporine, steroids', 'type': 'DRUG', 'armGroupLabels': ['Basiliximab-free']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}