Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT01670058
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2012-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pattern Of Use Of Belatacept In US Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2012-08-17', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of Belatacept use', 'timeFrame': 'Up to 72 months', 'description': 'Timeframe: Every 6 months up to 72 months'}, {'measure': 'Characteristics of Belatacept users, in terms of age, sex, ethnicity, transplanted organs, donor EBV infection-recipient EBV serostatus, donor CMV infection-recipient CMV serostatus, and the temporal trends in these characteristics', 'timeFrame': 'Up to 72 months', 'description': 'EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months'}, {'measure': 'Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with CNI-based regimens at the time of transplantation and temporal trends in these characteristics during 7 years post approval of Belatacept', 'timeFrame': 'Up to 72 months', 'description': 'Characteristics of adult kidney-only transplant recipients assessed are age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use.\n\nCNI = calcineurin inhibitors; Timeframe: Every 6 months up to 72 months'}], 'secondaryOutcomes': [{'measure': 'Characteristics of adult EBV seropositive kidney-only transplant recipients treated with Belatacept vs who are treated with CNI-based regimens at time of transplantation & temporal trends in these characteristics during 7 yrs post approval of Belatacept', 'timeFrame': 'Every 6 months up to 72 months', 'description': 'Characteristics of adult, EBV seropositive, kidney-only transplant recipients assessed are age, sex, ethnicity, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use'}, {'measure': 'Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients', 'timeFrame': 'Every 6 months up to 72 months'}, {'measure': 'Characteristics of switchers vs. non-switchers (age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use)', 'timeFrame': 'Every 6 months up to 72 months'}, {'measure': 'Temporal trend in switches during 7 years post-approval', 'timeFrame': 'Every 6 months up to 72 months'}, {'measure': 'CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in United Network for Organ Sharing (UNOS) and treated with Belatacept vs. CNIs at transplantation', 'timeFrame': 'Every 6 months up to 72 months'}, {'measure': 'CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in UNOS and switched to Belatacept, switched from Belatacept, or did not switch', 'timeFrame': 'Every 6 months up to 72 months'}, {'measure': 'Characteristics of Belatacept users stratified by EBV serostatus, including age, sex, ethnicity, general medical factors, transplant history (organ, date, graft failure date), and donor organ characteristics', 'timeFrame': 'Every 6 months up to 72 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation: Transplantation, Kidney']}, 'referencesModule': {'references': [{'pmid': '39792912', 'type': 'DERIVED', 'citation': 'Cherikh WS, Kou TD, Foutz J, Baker TJ, Gomez-Caminero A. Patterns of belatacept use and risk of post-transplant lymphoproliferative disorder in US kidney transplant recipients: An analysis of the Organ Procurement and Transplantation Network database. PLoS One. 2025 Jan 10;20(1):e0311935. doi: 10.1371/journal.pone.0311935. eCollection 2025.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': '* The prevalence of Belatacept use\n* The characteristics of Belatacept users and the temporal trends in these characteristics\n* Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the time of transplantation, and the temporal trends in these characteristics during 7 years post approval of Belatacept.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01670058', 'briefTitle': 'Pattern Of Use Of Belatacept In US Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Pattern Of Use Of Belatacept In US Transplant Recipients', 'orgStudyIdInfo': {'id': 'IM103-074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Belatacept treated adult kidney-only transplant recipients', 'description': 'All adult kidney-only transplant recipients treated with Nulojix (Belatacept)'}, {'label': 'CNIs at transplantation'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}