Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 4:14 AM
Study NCT ID:
NCT01509404
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2012-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077562', 'term': 'Valganciclovir'}, {'id': 'C045781', 'term': 'cytomegalovirus-specific hyperimmune globulin'}], 'ancestors': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fleminj@musc.edu', 'phone': '843-792-0312', 'title': 'James Fleming', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BK infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'CMV disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Graft loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Late CMV Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after 200 days post-transplant until 2 years post-transplant', 'description': 'Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Early CMV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Cell Mediated Immunity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Positive CMV quantiferon at last follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'title': 'GFR at 180 Days', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '123'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '78'}]}]}, {'title': 'GFR at 1 year', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '171'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '71'}]}]}, {'title': 'GFR at 2 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '143'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 12, and 24 months after transplant', 'description': 'Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Cellular and/or Antibody Mediated Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Opportunistic Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Asymptomatic CMV Viremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CMV Seroconversions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'OG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant\n\nValganciclovir: Valcyte per package insert guidelines for 200 days post transplant'}, {'id': 'FG001', 'title': 'Valcyte Then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection\n\nCMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant\n\nValganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Valcyte - Kidney Transplant', 'description': 'Subjects who received a kidney transplant and assigned to the Valcyte only Treatment arm.'}, {'id': 'BG001', 'title': 'Valcyte Then Cytogam - Kidney Transplant', 'description': 'Subjects who received a kidney transplant and assigned to the Valcyte then CytogamTreatment arm.'}, {'id': 'BG002', 'title': 'Valcyte - Liver Transplant', 'description': 'Subjects who received a liver transplant and assigned to the Valcyte only Treatment arm.'}, {'id': 'BG003', 'title': 'Valcyte Then Cytogam - Liver Transplant', 'description': 'Subjects who received a liver transplant and assigned to the Valcyte then Cytogam Treatment arm.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '71'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '69'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '58'}, {'value': '60', 'groupId': 'BG003', 'lowerLimit': '48', 'upperLimit': '61'}, {'value': '56', 'groupId': 'BG004', 'lowerLimit': '21', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Retransplant', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '71', 'spread': '20', 'groupId': 'BG000'}, {'value': '88', 'spread': '21', 'groupId': 'BG001'}, {'value': '84', 'spread': '13', 'groupId': 'BG002'}, {'value': '91', 'spread': '25', 'groupId': 'BG003'}, {'value': '84', 'spread': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-emptive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Pre-Emptive applies only to kidney transplant patients. Pre-emptive values were obtained by counting the number of patients who were not on dialysis prior to their kidney transplant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2012-01-10', 'resultsFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-06', 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Late CMV Disease', 'timeFrame': 'after 200 days post-transplant until 2 years post-transplant', 'description': 'Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Early CMV Infection', 'timeFrame': '100 days'}, {'measure': 'Number of Patients With Cell Mediated Immunity', 'timeFrame': '2 years', 'description': 'Positive CMV quantiferon at last follow-up'}, {'measure': 'Renal Function', 'timeFrame': '6, 12, and 24 months after transplant', 'description': 'Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant'}, {'measure': 'Number of Participants With Acute Cellular and/or Antibody Mediated Rejection', 'timeFrame': '2 years'}, {'measure': 'Number of Participants With Opportunistic Infections', 'timeFrame': '2 years'}, {'measure': 'Number of Participants With Asymptomatic CMV Viremia', 'timeFrame': '2 years'}, {'measure': 'Number of Participants With CMV Seroconversions', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['CMV', 'cytomegalovirus', 'transplant'], 'conditions': ['Cytomegalovirus Disease']}, 'referencesModule': {'references': [{'pmid': '39807668', 'type': 'DERIVED', 'citation': 'Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients ≥ 18 years of age.\n2. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.\n3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.\n4. The patient has given written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Solid organ transplant recipient is CMV seropositive at the time of transplant.\n2. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).\n3. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.\n4. Patients with thrombocytopenia (\\<25,000/mm3 ), with an absolute neutrophil count of \\< 1,000/mm3); and/or leucopoenia (\\< 2,000/mm3), or anemia (hemoglobin \\< 6 g/dL) prior to study inclusion.\n5. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.\n6. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.\n7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.\n8. Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.\n9. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.\n10. Inability to cooperate or communicate with the investigator.'}, 'identificationModule': {'nctId': 'NCT01509404', 'briefTitle': 'Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection', 'orgStudyIdInfo': {'id': 'Pro00009601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Valcyte', 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant', 'interventionNames': ['Drug: Valganciclovir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valcyte then Cytogam', 'description': 'valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection', 'interventionNames': ['Biological: CMV hyperimmune globulin', 'Drug: Valganciclovir']}], 'interventions': [{'name': 'Valganciclovir', 'type': 'DRUG', 'otherNames': ['Valcyte'], 'description': 'Valcyte per package insert guidelines for 200 days post transplant', 'armGroupLabels': ['Valcyte']}, {'name': 'CMV hyperimmune globulin', 'type': 'BIOLOGICAL', 'otherNames': ['Cytogam'], 'description': '100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant', 'armGroupLabels': ['Valcyte then Cytogam']}, {'name': 'Valganciclovir', 'type': 'DRUG', 'otherNames': ['Valcyte'], 'description': 'valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant', 'armGroupLabels': ['Valcyte then Cytogam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSL Behring', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}