Pattern Of Use Of Belatacept In US Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,000
- 主要终点
- The prevalence of Belatacept use
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant
排除标准
- 未提供
结局指标
主要结局
The prevalence of Belatacept use
时间窗: Up to 72 months
Timeframe: Every 6 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
时间窗: Up to 72 months
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
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
时间窗: Up to 72 months
EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months
次要结局
- 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)
- 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 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(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)
- 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)
- 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)