Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- post-transplant outcome
研究概览
简要总结
Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.
详细描述
Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.
At Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Received living or deceased donor kidney transplant during study period
- •Documented DGF
排除标准
- •Multiple organ transplant
- •Recipients with acute rejection present on first biopsy evaluation before first belatacept dose
- •Recipients with a first dose of belatacept after index discharge or tacrolimus initiation
结局指标
主要结局
post-transplant outcome
时间窗: 1 year
Patient survival o Graft survival Graft rejection
Time to renal recovery
时间窗: 1 year
weeks 1-4, and months 3, 6, 9 and 12) to capture potential short- and long-term effects on renal function.
次要结局
未报告次要终点