B Cell Lymphocyte in Humoral Rejection and Alloimmunisation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 26
- 主要终点
- Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings
研究概览
简要总结
This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.
详细描述
The principal objective is to better understand the B cell dependant mechanisms of the chronic antibody mediated rejection (cAMR). A particular focus will be done on the mechanisms that could explain the natural history of chronic humoral mediated rejection and of pathways from DSA negative status toward DSA positive status and from DSA positive status to histological lesions. The following will be undergone for three categories of patients (stable patients, DSA positive patients without cAMR and DSA positive patients with cAMR) :
- A phenotypic analysis of B cells of patients suffering from chronic humoral rejection or who are simply DSA positive.
- A functional analysis in autologous cultures in order to confirm our preliminary results.
- A functional analysis in a heterologous proliferation test aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR.
- A cytokine analysis (IL10, alpha-tumor necrosis factor, gamma-interferon dosing), for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.
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
- •Non stable patients :
- •Patient older than 18 years old.
- •Patient which is the recipient of a renal transplant
- •Patient who develops anti donor antibodies after the transplantation and / or suffering from a histologically-proven antibody mediated rejection.
- •Patient who has signed an informed consent form
- •Stable patients :
- •Patient older than 18 years old.
- •Patient that is the recipient of a renal transplant for more than one year
- •Patient who has accepted to participate in the Brest Kidney graft recipient collection
- •Patient that is not suffering from any rejection, that has a good renal function and a low proteinuria
- •Patient that has not developed any DSA.
排除标准
- •- Patients that has not signed the consent form.
结局指标
主要结局
Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings
时间窗: At the inclusion day
Evaluation of the proliferation of freshly isolated cells T in presence of autologous B cells
时间窗: At the inclusion day
cytokine analysis(IL10, alpha-Tumor Necrosis FActor, gamma-Interferon dosing)
时间窗: At the inclusion day
for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.
Evaluation of the proliferation of T cells in a heterologous test
时间窗: At the inclusion day
aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR
次要结局
- comparison of the B cell subpopulations before and after rituximab treatment(One year post inclusion)
- Correlation between phenotypic and functional evaluations, and clinical outcome(One year post inclusion)