Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation "REjet Cellules Immunitaires Transplantation rEnale" (RECITE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 570
- 主要终点
- Number of circulating CD3- CD56+ cells
研究概览
简要总结
We will study a prospective cohort including all kidney transplant recipients undergoing kidney graft biopsy in one kidney transplantation center, for a duration of 5 years.
Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection.
Our secondary outcomes are to describe the cellular, genetic, humoral, and histological characteristics of humoral rejection and their evolution.
详细描述
Information and inclusion visit (V0) The information and inclusion visit will be carried out on the day of the graft biopsy or, in the case of pre-scheduled biopsies, during a consultation prior to the biopsy (still as part of standard follow-up). This is particularly the case for patients undergoing systematic biopsy. The indication for graft puncture-biopsy is generally decided by the nephrologist in charge of the patient, or at departmental meetings for complex cases.
During this consultation, the physician verifies the inclusion criteria and obtains the patient's consent to take part in the study. We explain to the patient the scientific interest of evaluating the immune response in humoral rejection, and the absence of repercussions for the patient's subsequent management. A routine clinical examination is performed, and the patient's current treatment regimen is notified.
If the patient agrees, a blood sample is taken for the standard biology follow-up of transplant patients and for the study samples:
- Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum
- PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity
- Urine: 5 dry tubes or SST 5 ml maximum
Patients will be divided into two groups according to the indication for biopsy, with an influence on follow-up:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Kidney transplant recipient, male or female, 18 years of age or older
- •Patient undergoing a kidney allograft biopsy, according to the usual protocol of the service
- •Subject affiliated with a social health insurance scheme.
- •Subject capable of understanding the objectives and risks associated with the research and expressing non-opposition
排除标准
- •Inability to provide the subject with clear and proper information (difficulties in understanding the subject, ...)
- •Refusal of the patient to participate in the study
- •Subject under guardianship or curatorship
- •Subjects under legal protection
结局指标
主要结局
Number of circulating CD3- CD56+ cells
时间窗: Day of inclusion sample (= day of kidney allograft biopsy)
Comparison between patients with microvascular inflammation and other patients
次要结局
未报告次要终点