B Cell Lymphocyte in Humoral Rejection and Alloimmunisation (BHL)
2017年5月2日 更新者：University Hospital, Brest
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
125
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Amiens、法国、80054
- 完全的
- CHU Amiens
-
Angers、法国、49933
- 完全的
- CHU Angers
-
Brest、法国、29200
- 招聘中
- CHU Brest
-
Caen、法国、14033
- 完全的
- CHU Caen
-
Clermont Ferrand、法国、63003
- 完全的
- CHU Clermont Ferrand
-
Limoges、法国、87042
- 撤销
- CHU Limoges
-
Paris、法国、75743
- 完全的
- APHP Hôpital Necker
-
Poitiers、法国、86021
- 完全的
- CHU Poitiers
-
Reims、法国、51092
- 完全的
- CHU Reims
-
Rennes、法国、35033
- 完全的
- Chu Rennes
-
Rouen、法国、76230
- 完全的
- CHU Rouen
-
Strasbourg、法国、67091
- 完全的
- Hôpitaux Universitaires de Strasbourg
-
Tours、法国、37044
- 完全的
- CHU Tours
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
100 kidney graft recipients with DSA or cAMR (renal dysfunction, positive DSA, allograft nephropathy), and 25 stable patients of 13 French transplantation centres.
描述
Inclusion criteria :
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.
Exclusion criteria :
- Patients that has not signed the consent form.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
DSA positive patients without cAMR
Presence of DSA w/o cAMR
|
|
|
DSA positive patients with cAMR
Presence of DSA w/ cAMR
|
|
|
Stable patients
No DSA No cAMR
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of the ratio (percentage and absolute values) of mature LB subpopulations (LBm1 to LBm5) and of memory LB by specific labellings
大体时间：At the inclusion day
|
At the inclusion day
|
|
|
Evaluation of the proliferation of freshly isolated cells T in presence of autologous B cells
大体时间：At the inclusion day
|
At the inclusion day
|
|
|
Evaluation of the proliferation of T cells in a heterologous test
大体时间：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
|
At the inclusion day
|
|
cytokine analysis(IL10, alpha-Tumor Necrosis FActor, gamma-Interferon dosing)
大体时间：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.
|
At the inclusion day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between phenotypic and functional evaluations, and clinical outcome
大体时间：One year post inclusion
|
One year post inclusion
|
|
|
comparison of the B cell subpopulations before and after rituximab treatment
大体时间：One year post inclusion
|
In a subgroup of patients, the ones that will happen to be treated by rituximab for a rejection episode.
|
One year post inclusion
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年6月1日
初级完成 (预期的)
2017年12月1日
研究完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2016年8月30日
首先提交符合 QC 标准的
2017年1月9日
首次发布 (估计)
2017年1月10日
研究记录更新
最后更新发布 (实际的)
2017年5月4日
上次提交的符合 QC 标准的更新
2017年5月2日
最后验证
2017年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.