Pattern Of Use Of Belatacept In US Transplant Recipients

Study Overview
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Brief Summary
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The prevalence of Belatacept use The characteristics of Belatacept users and the temporal trends in these characteristics 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.

Official Title
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Pattern Of Use Of Belatacept In US Transplant Recipients

Conditions
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Kidney Transplantation: Transplantation, Kidney

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: The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant Exclusion Criteria:
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 adult kidney-only transplant recipients<br>All adult kidney-only transplant recipients treated with Nulojix (Belatacept) | |
| CNIs at transplantation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of Belatacept use | Timeframe: Every 6 months up to 72 months | Up to 72 months | 
| 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 | EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months | Up to 72 months | 
| 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 | 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. CNI = calcineurin inhibitors; Timeframe: Every 6 months up to 72 months | Up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Every 6 months up to 72 months | 
| Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients |  | Every 6 months up to 72 months | 
| 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) |  | Every 6 months up to 72 months | 
| Temporal trend in switches during 7 years post-approval |  | Every 6 months up to 72 months | 
| 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 |  | Every 6 months up to 72 months | 
| 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 |  | Every 6 months up to 72 months | 
| 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 |  | Every 6 months up to 72 months |