Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT00163657
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077561', 'term': 'Daclizumab'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], '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': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michelle.acker@baylorhealth.edu', 'phone': '214-820-2050', 'title': 'Goran Klintmalm, MD Director', 'organization': 'Baylor University Medical Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'biopsy, labs', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm 1', 'description': 'Immunosuppression TAC (tacrolimus) and CS (cyclosporine)', 'otherNumAtRisk': 80, 'otherNumAffected': 12, 'seriousNumAtRisk': 80, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Treatment Arm 2', 'description': 'Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)', 'otherNumAtRisk': 79, 'otherNumAffected': 79, 'seriousNumAtRisk': 79, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Treatment Arm 3', 'description': 'Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)', 'otherNumAtRisk': 153, 'otherNumAffected': 153, 'seriousNumAtRisk': 153, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 85, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 75, 'numAffected': 70}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Graft loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Acute Rejection or HCV Recurrence or Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm 1', 'description': 'Immunosuppression TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'OG001', 'title': 'Treatment Arm 2', 'description': 'Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'OG002', 'title': 'Treatment Arm 3', 'description': 'Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Freedom from acute rejection (Banff\\>grade 2 with RAI score\\>4) or freedom from HCV recurrence (Batts/Ludwig\\>Stage 2, or \\>Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm 1', 'description': 'Immunosuppression TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'OG001', 'title': 'Treatment Arm 2', 'description': 'Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'OG002', 'title': 'Treatment Arm 3', 'description': 'Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 month post transplant', 'description': 'Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm 1', 'description': 'Immunosuppression TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'FG001', 'title': 'Treatment Arm 2', 'description': 'Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'FG002', 'title': 'Treatment Arm 3', 'description': 'Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'graft loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment period August 15, 2002-March 29, 2004 Recruitment of liver transplant receipeints from centers transplant program', 'preAssignmentDetails': 'Subjects must be receiving a liver transplant for end stage chronic HCV'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm 1', 'description': 'Immunosuppression TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'BG001', 'title': 'Treatment Arm 2', 'description': 'Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)'}, {'id': 'BG002', 'title': 'Treatment Arm 3', 'description': 'Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Years', 'categories': [{'measurements': [{'value': '51.7', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '7.4', 'groupId': 'BG002'}, {'value': '51.6', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Reduce HCV recurrent post liver transplant', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients receiving a liver transplant for chronic HCV', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2005-09-09', 'resultsFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-15', 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Acute Rejection or HCV Recurrence or Treatment Failure', 'timeFrame': '12 months', 'description': 'Freedom from acute rejection (Banff\\>grade 2 with RAI score\\>4) or freedom from HCV recurrence (Batts/Ludwig\\>Stage 2, or \\>Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"'}, {'measure': 'Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure', 'timeFrame': '12 month post transplant', 'description': 'Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C Virus', 'Immunosuppressive Agents'], 'conditions': ['End Stage Liver Disease', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.', 'detailedDescription': 'End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver.\n\nBecause recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved.\n\nCorticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable.\n\nThis study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.\n2. Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C.\n3. Patient is \\> age 18.\n4. Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.\n\nExclusion Criteria:\n\n1. Patient has previously received or is receiving an organ transplant other than a liver.\n2. Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor.\n3. Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver.\n4. Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C).\n5. Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant.\n6. Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure.\n7. Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology.\n8. Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin.\n9. Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids.\n10. Patient is pregnant or lactating.\n11. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.\n12. Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.'}, 'identificationModule': {'nctId': 'NCT00163657', 'briefTitle': 'Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among 3 Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For ESLD Caused By Chronic Hepatitis C', 'orgStudyIdInfo': {'id': '02-01-L'}, 'secondaryIdInfos': [{'id': 'ZEN159', 'type': 'OTHER', 'domain': 'Baylor Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tacrolimus and cyclosporine', 'description': 'immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine', 'interventionNames': ['Drug: Daclizumub', 'Drug: Tacrolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MMF, tacrolimus and cyclosporine', 'description': 'immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine', 'interventionNames': ['Drug: Tacrolimus', 'Drug: Cyclosporine', 'Drug: MMF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'daclizumub, MMFand tacrolimus', 'description': 'immunosuppressant treatment regimens', 'interventionNames': ['Drug: Daclizumub', 'Drug: Tacrolimus', 'Drug: MMF']}], 'interventions': [{'name': 'Daclizumub', 'type': 'DRUG', 'otherNames': ['Zenapax'], 'description': 'anti-rejection drug', 'armGroupLabels': ['daclizumub, MMFand tacrolimus', 'tacrolimus and cyclosporine']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf'], 'description': 'anti rejection drug', 'armGroupLabels': ['MMF, tacrolimus and cyclosporine', 'daclizumub, MMFand tacrolimus', 'tacrolimus and cyclosporine']}, {'name': 'Cyclosporine', 'type': 'DRUG', 'otherNames': ['Neoral'], 'description': 'anti rejection drug', 'armGroupLabels': ['MMF, tacrolimus and cyclosporine']}, {'name': 'MMF', 'type': 'DRUG', 'otherNames': ['mycophenolate mofetil'], 'description': 'anti rejection drug', 'armGroupLabels': ['MMF, tacrolimus and cyclosporine', 'daclizumub, MMFand tacrolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Regional Transplant Institute - Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Goran Klintmalm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Univeristy Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No their is not a plan to make individual Participant data available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor Health Care System', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'Mayo Clinic - Scottsdale/Phoenix, Arizona', 'class': 'UNKNOWN'}, {'name': 'New York Presbyterian Hospital', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Mayo Clinic - Rochester, Minnesota', 'class': 'UNKNOWN'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'Lahey Clinic', 'class': 'OTHER'}, {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, {'name': 'Northwestern Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}