Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients
NCT ID: NCT01656343
Last Updated: 2022-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
775 participants
OBSERVATIONAL
2011-10-31
2019-08-05
Brief Summary
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* To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation
* To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone transplant recipients treated with CNI-based regimens at the time of transplantation
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Belatacept treated kidney-only transplant recipients
Belatacept
No Intervention
CNI treated kidney-only transplant recipients
Calcineurin inhibitors (CNI)
No Intervention
Interventions
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Calcineurin inhibitors (CNI)
No Intervention
Belatacept
No Intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* EBV seropositive, Kidney only transplant recipients initiated on belatacept and adult,
* EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the United Network for Organ Sharing (UNOS) during the period of recruiting belatacept users
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
References
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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.
Related Links
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BMS Clinical Trial Information
Investigator Inquiry form
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM103-075
Identifier Type: -
Identifier Source: org_study_id
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