Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT06091995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2023-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to renal recovery', 'timeFrame': '1 year', 'description': 'weeks 1-4, and months 3, 6, 9 and 12) to capture potential short- and long-term effects on renal function.'}, {'measure': 'post-transplant outcome', 'timeFrame': '1 year', 'description': 'Patient survival\n\no Graft survival Graft rejection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Use of Belatacept in Kidney Transplant Patients']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Nulojix (belatacept) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company; 2014.'}, {'pmid': '20415897', 'type': 'BACKGROUND', 'citation': 'Vincenti F, Charpentier B, Vanrenterghem Y, Rostaing L, Bresnahan B, Darji P, Massari P, Mondragon-Ramirez GA, Agarwal M, Di Russo G, Lin CS, Garg P, Larsen CP. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010 Mar;10(3):535-46. doi: 10.1111/j.1600-6143.2009.03005.x.'}, {'pmid': '20415898', 'type': 'BACKGROUND', 'citation': 'Durrbach A, Pestana JM, Pearson T, Vincenti F, Garcia VD, Campistol J, Rial Mdel C, Florman S, Block A, Di Russo G, Xing J, Garg P, Grinyo J. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57. doi: 10.1111/j.1600-6143.2010.03016.x.'}, {'pmid': '32400907', 'type': 'BACKGROUND', 'citation': 'Jorgenson MR, Descourouez JL, Brady BL, Bowman L, Hammad S, Kaiser TE, Laub MR, Melaragno JI, Park JM, Chandran MM. Alternatives to immediate release tacrolimus in solid organ transplant recipients: When the gold standard is in short supply. Clin Transplant. 2020 Jul;34(7):e13903. doi: 10.1111/ctr.13903. Epub 2020 May 29.'}, {'pmid': '28403127', 'type': 'BACKGROUND', 'citation': 'de Graav GN, Baan CC, Clahsen-van Groningen MC, Kraaijeveld R, Dieterich M, Verschoor W, von der Thusen JH, Roelen DL, Cadogan M, van de Wetering J, van Rosmalen J, Weimar W, Hesselink DA. A Randomized Controlled Clinical Trial Comparing Belatacept With Tacrolimus After De Novo Kidney Transplantation. Transplantation. 2017 Oct;101(10):2571-2581. doi: 10.1097/TP.0000000000001755.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.', 'detailedDescription': 'Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.\n\nAt Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age ≥18 years Received living or deceased donor kidney transplant during study period Treatment group: kidney transplant recipients with DGF that received belatacept Control group: kidney transplant recipients with DGF that did not receive belatacept', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Received living or deceased donor kidney transplant during study period\n* Documented DGF\n\nExclusion Criteria:\n\n* Multiple organ transplant\n* Recipients with acute rejection present on first biopsy evaluation before first belatacept dose\n* Recipients with a first dose of belatacept after index discharge or tacrolimus initiation'}, 'identificationModule': {'nctId': 'NCT06091995', 'briefTitle': 'Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function', 'orgStudyIdInfo': {'id': '030.PHA.2022.D'}}, 'armsInterventionsModule': {'interventions': [{'name': 'impact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)', 'type': 'BEHAVIORAL', 'otherNames': ['impact of administering one dose of belatacept on eGFR'], 'description': 'Evaluate the clinical impact of administering one dose of belatacept on eGFR at one-year post-transplant, patient and graft survival outcomes, graft rejection, and incidences of BK virus, EBV and CMV infections.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Erin Loncharic, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Health System'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at national scientific meetings and/or publication in open access journals. The PI will also make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.', 'accessCriteria': 'Clinical trials'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}