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临床试验/NCT06976008
NCT06976008尚未招募不适用

CMV-associated Immunomodulation in Renal Transplant Patients

Assistance Publique - Hôpitaux de Paris4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
4
主要终点
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients

研究概览

简要总结

Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.

详细描述

Cytomegalovirus (CMV) infection remains one of the most frequent and problematic complications of solid organ transplantation. Several epidemiological studies have shown an association between CMV infection and the occurrence of severe bacterial or fungal infections. However, the mechanisms by which CMV increases the risk of heterologous infection are still poorly understood. Several data support a direct or indirect immunomodulatory effect of CMV. Indeed, in healthy subjects, CMV seropositivity has a strong phenotypic and functional impact on adaptive immunity while in solid organ transplant patients, a decrease in the innate response to various antigenic stimuli has been observed during CMV viremia. The hypothesis of the study is that the occurrence of CMV viremia reduces the ability to develop optimal immune responses against other targeted pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • •st cohort :
  • •Age > 18 years
  • •patients with end-stage renal failure programmed for kidney transplantation with a live donor
  • •nd cohort :
  • •Age > 18 years
  • •kidney transplant recipient with CMV viremia

排除标准

  • •- Patients under guardianship, curatorship, legal protection.
  • •For patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :
  • •Patients with an active viral (other than CMV), bacterial or fungal infection at the time of inclusion
  • •patients receiving a desensitization protocol (ABO or anti-HLA)

研究组 & 干预措施

Kidney transplant recipients followed since the day of the transplantation

Experimental

Kidney transplant recipients followed since the day of the transplantation

干预措施: blood sampling (Other)

kidney transplant recipients with CMV viremia

Experimental

kidney transplant recipients with CMV viremia

干预措施: blood sampling (Other)

结局指标

主要结局

Impact of CMV infection on the heterologous innate immune response in kidney transplant patients

时间窗: 12 months

Comparison of the amount of cytokine production after stimulation of innate immune cells with whole microorganisms (E. Coli, Candida, Aspergillus, influenza virus) in solid organ transplant recipients with and without CMV over time.

次要结局

  • Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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