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临床试验/NCT03916497
NCT03916497已完成不适用

Quantification de l'immunité T Anti-CMV à l'Aide d'un Test IGRA Chez Des Patients greffés rénaux et Des Patients dialysés, Comparaison Avec Une Population de témoins

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Quantification of anti-CMV T cellular immunity in kidney transplant recipients, hemodialysis patients and control patients.

研究概览

简要总结

Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.

详细描述

Cytomegalovirus (CMV) infection is a common opportunistic complication after kidney transplantation (KT). It has been associated with high morbidity and mortality in kidney transplant recipients (KTR). Its actual management is only based on the humoral immunity : the main risk factor for CMV infection after KT is the association of a seropositive donor and a seronegative recipient (so-called "D+/R- mismatch").

However several studies have highlighted the essential role of cellular immunity to control CMV infection. The Quantiferon-CMV (QF-CMV) is an IGRA test (Interferon Gamma Releasing Assay) which evaluates T CD8 lymphocytes production of Interferon Gamma (IFNy) exposed to CMV antigens. Some studies have shown the possible interest of the QF-CMV in predicting CMV infection after antiviral prophylaxis discontinuation or when CMV viremia is detected.

However some limits have been underlined. First its positivity threshold hasn't been approved in KTR. Hemodialysis patients (HP) called to receive a renal allograft also suffered from altered immunity. No study has directly compared the QF-CMV value in KTR, HP and control patients.

That's why we propose evaluating the expression of basal cellular immunity against CMV (far from any active infection) in KTR and HP using the QF-CMV and comparing it to control patients population (not suffering from kidney dysfunction or immunosuppression).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Quantification of anti-CMV T cellular immunity in kidney transplant recipients, hemodialysis patients and control patients.

时间窗: Single measurement at Day 0 of patient inclusion

Quantification of IFNy level producted by T cells exposed to CMV antigens using a Quantiferon-CMV test in kidney transplant recipients, hemodialysis patients and control patients.

次要结局

  • Quantification of patient cellular immunity.(Single measurement at Day 0 of patient inclusion)
  • Assessment of CMV donor humoral immunity in kidney transplant recipients.(Single collection at Day 0 of patient inclusion)
  • Evaluation of kidney transplant recipient exposure to immunosuppressive therapy.(Single collection at Day 0 of patient inclusion)
  • Estimation of renal function.(Single measurement at Day 0 of patient inclusion)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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