Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study

Bristol-Myers Squibb89 enrolled

Overview

The purpose of the study is to estimate the incidence rates of Post-transplant Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult kidney-only transplant recipients treated with Belatacept, and compared the incidences to the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of transplantation.

Time Perspective: Prospective design, Retrospective data collection and analysis

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation Exclusion Criteria: * Patients with a history of malignancy

Outcomes

Primary Outcomes

Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)

Time frame: 5 years post transplantation

Incidences of hospitalized infections

Time frame: 2 years post transplantation

Incidences of malignancy

Time frame: 5 years post transplantation

Secondary Outcomes

Incidence rates of PTLD in adult subgroups of Belatacept- vs. CNI-treated, kidney-only transplant recipients defined by donor-recipient Epstein Barr virus (EBV) serostatus and by age groups

Time frame: Every 6 months and 12 months

Location, mortality, and tumor type of all PTLD cases in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation and in subgroups of these transplant recipients

Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation

Time frame: Every 6 months and 12 months

Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

Hospitalized infections for the following infection groups: 1. Bacterial 2. fungal 3. Viral 4. Tuberculosis 5. Herpes and 6. Cytomegalovirus (CMV)

Time frame: Every 6 months and 12 months

Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

Time frame: Every 6 months and 12 months

Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

Data from ClinicalTrials.gov

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