Donor Derived Cell-free DNA and Rejection of Kidney Allografts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
- 主要终点
- The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement
研究概览
简要总结
To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients transplanted from a deceased or living donor, who undergone a kidney allograft biopsy with clinical, biological, histological and immunological data.
- •Written informed consent at the time of transplantation for the center database
排除标准
- •Combined organ transplantation
- •Pregnant women
- •Bone marrow transplant
结局指标
主要结局
The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement
时间窗: The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients.
Biopsy-proven rejection refers to the confirmation of rejection through the examination of kidney allograft tissue obtained from a biopsy procedure. This includes different types of rejection, which are antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection. All the allograft biopsies will be classified according to the most recognized classification (Banff 2019 classification), which provides standardized criteria for the diagnosis and the characterization of the different types of rejection. To evaluate the association between dd-cfDNA and the occurrence of rejection, measurement of dd-cfDNA will be done at the time of each biopsy.
次要结局
未报告次要终点