Prediction of BK Virus Infection by Flow Cytometric Analysis of BK Virus-specific T Cell Responses in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- BKV-specific immune response
研究概览
简要总结
There has been no effective predicting tool to accurately predict BKV reactivation after kidney transplantation. The aim is to elucidate the use of flow cytometric analysis for both intracellular cytokines and surface activation markers for BKV-specific T cell response in kidney transplant recipients.
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
- 否
入选标准
- •New kidney transplantation cases (either living donor or deceased donor transplantation)
- •Age ≥ 18 years old
- •Agree to give a permission to blood sampling post-transplantation, and at the time of BK viremia.
排除标准
- •Primary non-function of kidney allograft (i.e. kidney allograft never function).
研究组 & 干预措施
BKV immune monitoring
- In this prospective cohort, the included kidney transplant recipients will receive regular post-transplantation care, including routine therapeutic drug monitoring of tacrolimus and screening for BK viremia. No extra medications beyond the standard of care will be given to the patients in this study.
- Whole blood will be drawn from kidney transplant recipients on day 30, day 180, and at the time of BK viremia. PBMCs will be separated and incubated with BK viral peptides.
- PBMCs will be stained for surface marker of activated T cells and intracellular cytokines 4. Phenotypic features of T cells will be analyzed under flow cytometry and correlated with the occurrence of BKV infection and immunosuppressive medications.
干预措施: BKV immune monitoring (Diagnostic Test)
结局指标
主要结局
BKV-specific immune response
时间窗: Day 30, Day 90 after transplantation before BK viremia
\- To examine the capability of flow cytometry in predicting post-kidney transplant BKV infection, by the analyses of intracellular cytokines (interleukine-2) and surface activation markers (CD25) of T cells
BKV-specific immune response
时间窗: Day 30, Day 90 after transplantation before BK viremia
\- To examine the capability of flow cytometry in predicting post-kidney transplant BKV infection, by the analyses of intracellular cytokines (interleukine-2) and surface activation markers (CD25) of T cells
次要结局
- BKV-specific immune response and immunosuppression regimen(Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications)
- Dynamic change of BKV-specific immune response(Day 30, Day 90 after transplantation, irrespective ly to BK viremia)
研究者
Suwasin Udomkarnjananun
Assistant Professor
King Chulalongkorn Memorial Hospital