Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy
研究概览
简要总结
Chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. Despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival.
Different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (HLA) incompatibilities between the donor and the recipient. However, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies.
Also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation.
The onset of acute rejection is caused by the ability of the recipient's T cells to recognize alloantigens. The CD45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the T cell.
Investigators showed that the level of expression of CD45RC on T lymphocytes was associated with the risk of acute rejection. Thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating CD8 lymphocytes expressing high CD45RC (CD45RChigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of CD8+CD45RChigh.
The purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 and under 70 years old
- •Patients in care for a first priority renal transplant.
- •Patients with low immunological risk
- •Patients with prior written informed consent
排除标准
- •Poor understanding of the French language
- •Pregnant, breastfeeding or partying women
- •Persons deprived of liberty by an administrative or judicial decision
- •Persons undergoing psychiatric care under duress
- •Adults who are subject to a legal or non-state protection measure to express their consent
结局指标
主要结局
Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy
时间窗: 12 months
次要结局
- Rate of CD45RC for patient with acute rejection suspicion(12 months)
- Rate of CD4, CD8, CD45RA, CD25, CD127, CD19 markers on T cells the day of acute rejection(12 months)
- anti-HLA antibodies' dosage at the time of acute rejection(12 months)
- Rate of CD45RC on circulating T lymphocytes the day of acute rejection(12 months)
- cytokines' dosage(Day 1)
- Rate of CD45RC on circulating T lymphocytes(from date of randomization until the date of acute rejection, up to 12 months)