Predictive Value Analysis of Messenger Ribonucleic Acid (mRNA) Urinary Expression of Foxp3 and Vimentin on Graft Outcome in Renal Transplant Recipient: National Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Foxp3 and Vimentin mRNA expression
研究概览
简要总结
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.
详细描述
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function,
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
- •All renal transplant recipients aged >18 years with informed consent
- •Kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the Agency of Biomedicine
- •Supported by a conventional procedure
- •Informed consent signed.
- •No pregnancy or lactation in progress.
- •Serology HIV and (HCV negative suppressed by amendment n°2)
- •No contraindication for a biopsy at 1 year post transplant
排除标准
- •Positive crossmatch, focal segmental glomerulosclerosis (FSGS) as primary nephropathy, HIV positive population
- •Absence of registration on the waiting list for transplantation with the Agency of Biomedicine
- •HIV-positive serology
- •Chronic renal failure secondary to focal segmental hyalinosis
- •Cross-match historical or cross match of the day positive T or B awareness
- •Patient included in a Memorandum of industry (suppressed by amendment n°1)
- •No affiliation to a social security scheme
- •Patients with early failure due to immediate complications (4%) will be included but will not be considered for analysis
结局指标
主要结局
Foxp3 and Vimentin mRNA expression
时间窗: at Month 1,3,6 and 12
evaluation at month 9 suppressed by amendment n°2
次要结局
- Renal biopsy(at Month 12)