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临床试验/NCT07134491
NCT07134491招募中不适用

Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年3月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
Characterization of lymphocytes in humoral rejection

研究概览

简要总结

Humoral rejection of kidney transplants is responsible for a large number of kidney graft losses in a context of increasing shortage.

Although it has been established that it is largely mediated by the alloreactive B lymphocyte, anti-B therapies are only partially effective.

The mechanisms behind the loss of tolerance are also poorly understood, and the triggers of rejection remain to be elucidated.

During this study, patients admitted for kidney graft biopsy for suspicion of rejection will be included ; patients presenting non inflammatory biopsies will be studied as controls. B cells will be extracted and cultured. Their antibodies will be studied along with reactivity towards HLA, non HLA targets and the gut microbiome. The same study will be led for late rejections needing graft removal : B cells extraction, culture, antibodies reactivity testing. Controls will be graft removal for non inflammatory causes. In both cases hight throughput sequencing the immunoglobulin genes will be performed.

研究设计

研究类型
Observational
观察模型
Case Control
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
否

入选标准

  • •Adult kidney transplant recipients admitted for biopsy or graft removal in the participating nephrology departments.
  • •Patient participation agreement and signed consent form
  • •Affiliation to a health insurance system

排除标准

  • •Confounding factor of renal inflammation: acute or recurrent pyelonephritis, BK virus nephropathy
  • •Pregnant or breast-feeding women
  • •Persons under legal protection

研究组 & 干预措施

kidney biopsy or graft removal for rejection

Renal transplant recipients with suspicion of rejection or undergoing kidney biopsy or graft removal

干预措施: Piece of kidney removal (Biological)

kidney biopsy or graft removal for rejection

Renal transplant recipients with suspicion of rejection or undergoing kidney biopsy or graft removal

干预措施: Stool collection (Biological)

kidney biopsy or graft removal for rejection

Renal transplant recipients with suspicion of rejection or undergoing kidney biopsy or graft removal

干预措施: Blood collection (Biological)

kidney biopsy or graft removal for reasons other than rejection

Renal transplant recipients with undergoing kidney graft removal or biopsy for reansons other than rejection

干预措施: Piece of kidney removal (Biological)

kidney biopsy or graft removal for reasons other than rejection

Renal transplant recipients with undergoing kidney graft removal or biopsy for reansons other than rejection

干预措施: Stool collection (Biological)

kidney biopsy or graft removal for reasons other than rejection

Renal transplant recipients with undergoing kidney graft removal or biopsy for reansons other than rejection

干预措施: Blood collection (Biological)

结局指标

主要结局

Characterization of lymphocytes in humoral rejection

时间窗: Day 1

Using Flow cytometry analysis

次要结局

  • Analyze of gut microbiota of kidney transplant patients(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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