Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-06 @ 4:02 PM
Study NCT ID:
NCT02736227
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2016-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j-levitsky@northwestern.edu', 'phone': '312-695-4413', 'title': 'Josh Levitsky', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Graft Rejection After Tacrolimus Was Discontinued (REJ)', 'description': 'Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Graft Rejection After Tacrolimus Weaning (Non REJ)', 'description': 'NON-REJ patients did not required liver biopsy during the trial', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Withdrew From Study Before Tacrolimus Weaning', 'description': 'Removed from study before Tac withdrawal started', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Graft Rejection After Tacrolimus Was Discontinued (REJ)', 'description': 'Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6'}, {'id': 'OG001', 'title': 'No Graft Rejection After Tacrolimus Weaning (Non REJ)', 'description': 'NON-REJ patients did not required liver biopsy during the trial'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '1', 'groupId': 'OG000'}, {'value': '5', 'spread': '.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months post transplantation', 'description': 'flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)', 'unitOfMeasure': 'percentage of CD4 positive cell', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '15 patients did not reject and 5 had mild rejection responding to tacrolimus resumption.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Graft Rejection After Tacrolimus Was Discontinued (REJ)', 'description': 'Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6'}, {'id': 'FG001', 'title': 'No Graft Rejection After Tacrolimus Weaning (Non REJ)', 'description': 'NON-REJ patients did not required liver biopsy during the trial'}, {'id': 'FG002', 'title': 'Removed From Study Before Tac Withdrawl Started', 'description': 'Removed from study before Tac withdrawl started'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Non Compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'From May 2016 to May 2018, 170 adult primary LT were performed at our center. 20 Subjects underwent tac (Tacrolimus)withdrwal.\n\n28 patients consented but 8 were removed\n\nFinal sample for analysis is n=20', 'preAssignmentDetails': '28 patients consented but 8 were removed (n=1 withdrew, n=2 non compliant with protocol, n=2 new wound issues, n=1 high urine protein/creatinine ration and n=2 had neutropenia) Final sample for analysis is n=20'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Graft Rejection After Tacrolimus Was Discontinued (REJ)', 'description': 'Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6'}, {'id': 'BG001', 'title': 'No Graft Rejection After Tacrolimus Weaning (Non REJ)', 'description': 'NON-REJ patients did not required liver biopsy during the trial'}, {'id': 'BG002', 'title': 'Withdrew From Study Before Tacrolimus Weaning', 'description': 'These subjects were removed after consenting. These subjects were not initiated on TAC weaning'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '67.4', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '56', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '7.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatocellular Carcinoma', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Measure Analysis Population Description: Data was not collected for participant in the "Withdrew from study before Tacrolimus Weaning" Arm', 'unitOfMeasure': 'participants', 'populationDescription': 'no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Primary Liver Disease- Hep C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Liver Disease- Alcohol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Liver Disease- Non Alcoholic Fatty Liver', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Liver Disease- Other', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tacrolimus Trough', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '5.2', 'spread': '1.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Measure Analysis Population Description: Data was not collected for participant in the "Withdrew from study before Tacrolimus Weaning" Arm', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Everolimus Trough', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '2.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -White Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '1000 *cells*/mm^3', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -Hb', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '11', 'spread': '2.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -Platelet count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '144.6', 'spread': '47.6', 'groupId': 'BG000'}, {'value': '111.9', 'spread': '59.2', 'groupId': 'BG001'}, {'value': '119.7', 'spread': '57.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '1000 *cells*/mm^3', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -eGFR-MDRD', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55.2', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '60.3', 'spread': '17.7', 'groupId': 'BG001'}, {'value': '59', 'spread': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -Total Bilirubin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -AST', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '17.3', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'u/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -ALT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28.2', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '19.1', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '21.3', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'u/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}, {'title': 'Lab Value -Alk Phos', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '95.2', 'spread': '47.7', 'groupId': 'BG000'}, {'value': '69.9', 'spread': '24.6', 'groupId': 'BG001'}, {'value': '75.9', 'spread': '32.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'u/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-06', 'size': 5194440, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-02T17:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-04', 'studyFirstSubmitDate': '2016-03-24', 'resultsFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-04', 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection', 'timeFrame': 'Six months post transplantation', 'description': 'flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver transplantation', 'immunosuppression', 'everolimus', 'tacrolimus', 'kidney function', 'liver function', 'biomarkers'], 'conditions': ['Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult LT candidates ≥ 18 years of age\n* Listed for or recent (within 1 month) recipient of deceased or living donor liver transplantation\n\nExclusion Criteria:\n\n* Combined or previous organ transplantation\n* Human immunodeficiency virus (HIV) infection\n* Inability to provide informed consent or comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT02736227', 'briefTitle': 'Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation', 'orgStudyIdInfo': {'id': 'STU00201794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tacrolimus Withdrawal and Everolimus Monotherapy', 'description': 'Tacrolimus will be tapered while continual use of everolimus.', 'interventionNames': ['Drug: Tacrolimus Withdrawal and Everolimus Monotherapy']}], 'interventions': [{'name': 'Tacrolimus Withdrawal and Everolimus Monotherapy', 'type': 'DRUG', 'description': 'During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures. At one month post-transplant, mycophenolic acid will be stopped and tacrolimus dosage will be reduced while continuing the dosage of everolimus. At three months post-transplant, tacrolimus dosage will be reduced by 50% of the daily dose each week. At four months post-transplant, tacrolimus will be discontinued.', 'armGroupLabels': ['Tacrolimus Withdrawal and Everolimus Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Comprehensive Transplant Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Josh Levitsky, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Medicine-Gastroenterology and Hepatology and Surgery-Organ Transplantation', 'investigatorFullName': 'Josh Levitsky', 'investigatorAffiliation': 'Northwestern University'}}}}