Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,000
- 主要终点
- QScore specificity and sensitivity in relation to kidney biopsy
研究概览
简要总结
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.
详细描述
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. Each participant will be tracked for 24 months. QSant testing will be performed according to the intended use guidelines specified in "LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (SCr/eGFR) as described in the study schedule. Participants will be compared to a site-specific retrospective cohort of KTRs without QSant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from UNOS (United Network for Organ Sharing) data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney 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 augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.
结局指标
主要结局
QScore specificity and sensitivity in relation to kidney biopsy
时间窗: 6 weeks before each biopsy-proven rejection (BPAR)
Demonstrate sensitivity and specificity of QSant for detecting biopsy-proven rejection (BPAR), defined as t-score ≥1. For this aim QSant detection will be based on a threshold of \>32 within 6 weeks of BPAR (using the most recently collected result)
次要结局
未报告次要终点