Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT03823768
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2019-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Envarsus Neurotoxicity Burden in Liver Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'taberd@musc.edu', 'phone': '8437922724', 'title': 'Professor', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study conducted during COVID 19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': '6 months post-transplant', 'description': 'SAE was defined as a hospitalization, prolonged hospitalization, graft loss or death.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Control', 'description': 'Tacrolimus immediate release twice daily for 6 months\n\nTacrolimus Immediate release: Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Intervention', 'description': 'Envarsus daily for 6 months.\n\nEnvarsus: Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Acute Rejection', 'notes': 'Liver rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Neurotoxicity Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Control', 'description': 'Tacrolimus immediate release twice daily for 6 months\n\nTacrolimus Immediate release: Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.'}, {'id': 'OG001', 'title': 'Arm 2: Intervention', 'description': 'Envarsus daily for 6 months.\n\nEnvarsus: Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-13.5', 'upperLimit': '-0.25'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-9.5', 'upperLimit': '-0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score (PGI-I, with a range of 4-28) The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). Scale min=4, scale max=28. The scale is made up of four questions, each question has a total of 7 responses, the total score is the sum of each questions choice (1-7). Higher values represent a worsening condition. A score of 16 would indicate no overall change. A score of 15 or lower indicates improvement in the condition and a score of 17 or higher indicates a worsening of the condition. A score of 28 would indicate "very much worse," while a score of 4 would indicate "very much better." A relative change of 2 points would be considered a significant change from baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Control', 'description': 'Tacrolimus immediate release twice daily for 6 months\n\nTacrolimus Immediate release: Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.'}, {'id': 'FG001', 'title': 'Arm 2: Intervention', 'description': 'Envarsus daily for 6 months.\n\nEnvarsus: Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Control', 'description': 'Tacrolimus immediate release twice daily for 6 months\n\nTacrolimus Immediate release: Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.'}, {'id': 'BG001', 'title': 'Arm 2: Intervention', 'description': 'Envarsus daily for 6 months.\n\nEnvarsus: Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '13', 'groupId': 'BG000'}, {'value': '52', 'spread': '9', 'groupId': 'BG001'}, {'value': '52', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-10', 'size': 981702, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-09T08:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2019-01-29', 'resultsFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-25', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Neurotoxicity Burden', 'timeFrame': '6 months', 'description': 'Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score (PGI-I, with a range of 4-28) The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). Scale min=4, scale max=28. The scale is made up of four questions, each question has a total of 7 responses, the total score is the sum of each questions choice (1-7). Higher values represent a worsening condition. A score of 16 would indicate no overall change. A score of 15 or lower indicates improvement in the condition and a score of 17 or higher indicates a worsening of the condition. A score of 28 would indicate "very much worse," while a score of 4 would indicate "very much better." A relative change of 2 points would be considered a significant change from baseline.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurotoxicity', 'Liver Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '41089174', 'type': 'DERIVED', 'citation': 'Coffman KS, Revuelta GJ, DeTurk N, Palmer C, Culpepper H, Overstreet M, Fleming J, Terry K, Patel N, McGillicuddy J, Nagaraju S, Rice TC, Taber DJ. Results of a Randomized Controlled Trial Evaluating the Impact of Conversion to LCP Tacrolimus on Neurologic Toxicities in Liver Transplant Recipients. Int J Hepatol. 2025 Oct 6;2025:4374144. doi: 10.1155/ijh/4374144. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.\n2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.\n\nExclusion Criteria:\n\n1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner\n2. HIV positive (HIV ab +)\n3. Unable to tolerate oral medications\n4. Use of another investigational product within thirty days prior to receiving study medication\n5. Moderate acute cellular rejection (RAI ≥ 5) within the past month\n6. A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.\n7. Patients taking medications known to induce tremors or dopamine blocking agents\n8. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject'}, 'identificationModule': {'nctId': 'NCT03823768', 'briefTitle': 'Envarsus Neurotoxicity Burden in Liver Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients', 'orgStudyIdInfo': {'id': '00083855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Control', 'description': 'Tacrolimus immediate release twice daily for 6 months', 'interventionNames': ['Drug: Tacrolimus Immediate release']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Intervention', 'description': 'Envarsus daily for 6 months.', 'interventionNames': ['Drug: Envarsus']}], 'interventions': [{'name': 'Envarsus', 'type': 'DRUG', 'description': 'Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.', 'armGroupLabels': ['Arm 2: Intervention']}, {'name': 'Tacrolimus Immediate release', 'type': 'DRUG', 'description': 'Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.', 'armGroupLabels': ['Arm 1: Control']}]}, '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}}], 'overallOfficials': [{'name': 'Derek Dubay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Veloxis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor-Faculty', 'investigatorFullName': 'David J. Taber', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}