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

Study Overview
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Brief Summary
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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.

Detailed Description
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Time Perspective: Prospective design, Retrospective data collection and analysis

Official Title
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Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)

Conditions
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Kidney Transplantation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving Belatacept in CTS<br>Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation | |
| Patients receiving CNI in CTS<br>Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) |  | 5 years post transplantation | 
| Incidences of hospitalized infections |  | 2 years post transplantation | 
| Incidences of malignancy |  | 5 years post transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 | 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: Bacterial fungal Viral Tuberculosis Herpes and Cytomegalovirus (CMV) | 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 |  | 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 |  | Every 6 months and 12 months | 
| Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections |  | 2 years post transplantation |