Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Biopsy prove acute rejection
研究概览
简要总结
This is a single-center, prospective, non-randomized, observational study to evaluate specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely monitored over one year after enrollment.
详细描述
OBJECTIVE
The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who meet all of the following criteria are eligible for enrollment as study participants:
- •Male and female recipients of all races, ≥18 years of age.
- •Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
- •Subject and/or guardian must be able to provide informed consent.
- •Subject and/or guardian must be able to comply with the study protocol.
排除标准
- •Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- •Recipients of previous non-renal solid organ and/or islet cell transplantation
- •Infection with HIV.
- •Inability or unwillingness of a participant and/or guardian to provide informed consent
结局指标
主要结局
Biopsy prove acute rejection
时间窗: 12 months
Incidence of acute rejection at the time of any kidney biopsy
次要结局
- Gene Expression Profiling(12 months)