Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 2
- 主要终点
- Renal Function Decline
研究概览
简要总结
The purpose of this study is to determine if certain genes found in a kidney biopsy performed at one-year post transplant can predict which transplanted kidneys will have decreased kidney function within five years post-transplant.
详细描述
Gene expression profiling is used to study the activity of genes. Each gene has an "on/off" switch that controls how they are expressed in a cell, as well as a "volume control" that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.
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
- •Adult (≥18 years) conventional renal transplant recipient.
- •Patients who have given informed consent and are willing to comply with the protocol.
排除标准
- •ABO incompatible kidney transplants.
- •Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric crossmatch >150).
- •Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, etc. Subjects who had previous extra renal transplants may be included in the study.
- •Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal biopsy.
- •An inability to have the 1-year renal biopsy performed within the acceptable protocol window (Months 11-14 [Days 301-420] post-transplant).
结局指标
主要结局
Renal Function Decline
时间窗: Baseline to 1 year
The primary endpoint for this study is defined as a progressive decline in renal function in participants with good function at 1 year. These "Progressors" are defined by all of the following criteria: 1. 1 year estimated GFR (eGFR) by MDRD equation of \>40 ml/min. 2. Decline in eGFR beyond 1 year during the time frame of this study (minimum 2.6 years after transplant and up to 5 years after transplant) with a slope of \<-6.1% (i.e. slope of decline of renal function is \>6.1%). 3. \>20% decline in eGFR from 1 year post-transplant to latest follow-up point. 4. At least one eGFR (MDRD) interval \< 60 ml/min.
次要结局
未报告次要终点