Prospective Assessment of Rejection in Kidney Transplant (PARK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- QScore specificity and sensitivity in relation to kidney biopsy
研究概览
简要总结
The PARK study is a multi-center observational study to assess the performance of the QSant test with kidney biopsy.
QSant is a test based on 6 urinary biomarkers that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection.
详细描述
Non-randomized, unblinded observational study to collect urine samples, coincident allograft biopsy results, and relevant clinical data to evaluate the QSant test.
Participants will be recruited prior to or on the day of an already scheduled kidney biopsy.
Urine samples will be collected before biopsy (protocol and for-cause).
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 transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
- •Kidney biopsy scheduled on a date > 14 days post-transplant
- •Able to understand risks and requirements of participation and provide informed consent
- •Willing and able to comply with the study requirements
排除标准
- •Inability to provide a voided urine sample per collection protocol
- •Urological abnormalities such as catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
- •History of or current multi-organ transplant
结局指标
主要结局
QScore specificity and sensitivity in relation to kidney biopsy
时间窗: Prior to biopsy
Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy
Collect coincident urine specimens and biopsy results from participants
时间窗: Prior to biopsy
Collect urine sample using QSant kit for adult kidney transplant recipients
次要结局
未报告次要终点