Molecular HistoMx Assessment for Kidney Transplant Rejection and Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice
研究概览
简要总结
Transcriptomic analysis of kidney biopsies has demonstrated the potential to improve diagnosis of graft rejection. Molecular assessment of kidney graft rejection based on the Banff Human Organ Transplant consensus gene panel is an available and validated tool (HistoMx). However the applicability of molecular assessment of graft biopsy in real life setting is unclear. The main objective is to assess the clinical need of molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice. The secondary objectives are to measure : clinical outcomes at 12-months follow up including patient survival, graft function and graft survival, diagnosis of graft rejection after integrating molecular assessment to standard histology, biology and immunology, and to evaluate therapeutic changes and impact on clinical outcome.
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 recipients older than 18 years of age
- •Patients receiving a kidney transplant from a living or brain-dead donor
排除标准
- •Patients who have received a previous transplant with an organ other than the kidney
- •Patients without available graft biopsy material for molecular HistoMx testing
研究组 & 干预措施
Kidney transplant recipients from two referral academic center were enrolled in the study
干预措施: No intervention (Other)
结局指标
主要结局
Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice
时间窗: 12 months
The main objective is to assess the clinical indication and rate of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice
次要结局
- Graft function at 12 months after graft biopsy(12 months)
