NCT04266613终止不适用
Molecular Biomarkers in Renal Transplant Recipients at Higher Risk of Acute Rejection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Clinical Utility of TruGraf Results
研究概览
简要总结
This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.
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
- •High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody >75%.
- •Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
- •Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels).
- •Kidney transplant patients who are at least 30 days post-transplant.
排除标准
- •Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- •Recipients who do not meet criteria of high-immune risk.
- •Recipients of previous non-renal solid organ and/or islet cell transplantation.
- •Infection with HIV.
- •Infection with BK.
- •Patients that have nephrotic proteinuria (urine protein >3 gm/day).
结局指标
主要结局
Clinical Utility of TruGraf Results
时间窗: 1 year
Percent of total number of TruGraf results that the PI identified as having clinical utility
Correlation of TruGraf Results
时间窗: 1 year
Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care
次要结局
未报告次要终点
研究者
研究点 (1)
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