Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

Study Overview
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Brief Summary
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To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation 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

Official Title
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Belatacept and Risk of PTLD in US Renal Transplant Recipients

Conditions
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Kidney Transplantation, Transplantation, Kidney

Intervention / Treatment
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* Drug: Calcineurin inhibitors (CNI)
* Drug: Belatacept


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Adult, 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

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 |
| --- | --- |
| Belatacept treated kidney-only transplant recipients<br> | Drug: Belatacept<br>* No Intervention<br>* Other names: Nulojix;|
| CNI treated kidney-only transplant recipients<br> | Drug: Calcineurin inhibitors (CNI)<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation |  | Every 6 months for up to 72 months | 
| Incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation |  | Every 6 months for up to 72 months | 
| Ratio for PTLD incidence rates in adult, EBV seropositive, kidney alone, belatacept treated patients and adult EBV seropositive, kidney alone, CNI-treated patients at the time of transplantation |  | Every 6 months for up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient Epstein-Barr virus (EBV) serostatus (negative or unknown) and by donor to recipient EBV serostatus |  | Every 6 months for up to 72 months | 
| Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by EBV serostatus (negative or unknown) to the rates in corresponding CNI-treated subgroups |  | Every 6 months for up to 72 months | 
| Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient cytomegalovirus (CMV) serostatus and by donor to recipient CMV serostatus |  | Every 6 months for up to 72 months | 
| Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by CMV serostatus to the rates in corresponding CNI-treated subgroups |  | Every 6 months for up to 72 months | 
| Characteristics (age, gender, weight, BMI, use of immunosuppressive medications, and type of induction medications) of PTLD cases, and the location and mortality of PTLD | Characteristics in adult, kidney alone transplant recipients treated with belatacept at transplantation and in subgroups of these transplant recipients defined by EBV serostatus and CMV serostatus | Every 6 months for up to 72 months | 
| Ratio for characteristics of PTLD cases, and the location and mortality of PTLD, in adult, kidney alone transplant recipients treated with belatacept at transplantation to those treated with CNI-based regimens at transplantation |  | Every 6 months for up to 72 months | 
| Two year incidence rates of PTLD by calendar year of transplantation in adult, kidney alone transplant recipients treated with belatacept at transplantation, and in subgroups of these transplant recipients defined by EBV serostatus and by CMV serostatus |  | Every 6 months for up to 24 months | 
| Incidence rates of PTLD by immunosuppressive regimen changes in adult, kidney alone transplant recipients who switch to or from belatacept during the period from transplant to the end of one-year follow-up |  | Every 6 months for up to 12 months follow up |