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临床试验/NCT04506060
NCT04506060已完成不适用

Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2020年9月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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