Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient
研究概览
简要总结
Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •adult kidney transplanted patients
- •Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation.
排除标准
- •Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)
结局指标
主要结局
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient
时间窗: one year
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa.
次要结局
未报告次要终点
