Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.
研究概览
简要总结
The aim of the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection.
The aim of the study is to determine an early transcriptional profile of chronic rejection in the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional analysis will be based on graft function and graft histology one year after transplantation.The other aim is to determine an early transcriptional profile of operational tolerance in the same patients using a DNA chip dedicated including two lists of genes discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.
To allow statistical analysis of 100 patients followed one year after graft, patients not assessable at one year due to early termination of study will be replaced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years old,
- •Donor's age ≤ 60 years old,
- •Patients receiving a first cadaveric renal graft,
- •Patients taking immunosuppressant treatment including an induction with Simulect at day 0 and day 4, FK 506 (Prograf®) associated with Cellcept and steroids (for three months),
- •Patients don't taking indispensable anticoagulant treatment.
排除标准
- •Patient's age < 18 or > 65 years old,
- •Donor's age ≥ 60 years old,
- •Pregnant women or breast feeding women,
- •Patients receiving a retransplantation, a kidney and pancreas graft or a graft from a living donor,
- •Patients taking immunosuppressant treatment without FK 506 (Prograf®), Cellcept and steroids.
- •Patients with coagulation troubles or taking indispensable anticoagulant treatment,
- •No biopsy before graft.
结局指标
主要结局
Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.
时间窗: 3 months
次要结局
- Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up.(One year)