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