A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Feasibility of TruGraf Testing
研究概览
简要总结
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. 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
- •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 >90 days (+/- 2 weeks) post-transplant will be included in this study
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.
- •Infection with BK nephropathy.
- •Patients that have nephrotic proteinuria (urine protein >3 gm/day).
结局指标
主要结局
Feasibility of TruGraf Testing
时间窗: through study completion, an average of 6 months
Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow
Clinical Utility of TruGraf Results
时间窗: through study completion, an average of 6 months
Percent of total number of TruGraf results that the PI identified as having clinical utility
Correlation of TruGraf Results
时间窗: through study completion, an average of 6 months
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