NCT01471223已完成不适用
Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)
Bristol-Myers Squibb0 个研究点目标入组 89 人开始时间: 2012年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 主要终点
- Incidences of malignancy
研究概览
简要总结
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.
详细描述
Time Perspective: Prospective design, Retrospective data collection and analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with a history of malignancy
结局指标
主要结局
Incidences of malignancy
时间窗: 5 years post transplantation
Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)
时间窗: 5 years post transplantation
Incidences of hospitalized infections
时间窗: 2 years post transplantation
次要结局
- 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(Every 6 months and 12 months)
- Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections(2 years post transplantation)
- Cumulative incidence of hospitalized infections 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 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)
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