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临床试验/NCT07256470
NCT07256470尚未招募不适用

Salivary Replication of BK Virus in Post-kidney Transplant

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Number of BK positive saliva and blood samples

研究概览

简要总结

BK virus infection in kidney transplantation can compromise graft function. Current data suggest that BK virus nephropathy results not only from transmission of virus from the donor but also from reactivation of latent virus in the recipient. However, no study has investigated the possibility of respiratory transmission. This study would provide a better understanding of the pathophysiology of BK virus infection in kidney transplant recipients. The investigators would study viral replication of BK virus in saliva, urine and blood of patients who received a kidney transplant at the Amiens University Hospital. For this, the investigators will collect salivary self-collection on the day of the kidney transplant then at 1, 3, 6, 9 and 12 months as well as a urine and blood sample. The investigators will measure BK viral load in these three samples at different times.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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

  • kidney transplant recipients
  • age ≥ 18 years

排除标准

  • age < 18 years
  • absence of consent

结局指标

主要结局

Number of BK positive saliva and blood samples

时间窗: 12 months

Compare the positivity of the BK virus viral load between the saliva sample and the urine and blood samples

次要结局

  • urinary BK virus concentration(12 months)
  • variation of BK virus genome(12 months)
  • Immunoglobin concentrations(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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