GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 10
- 主要终点
- Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
研究概览
简要总结
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject is 18 years of age or older
- •At least 12 calendar days have elapsed since the subject received a kidney transplant.
- •Subject has provided legally effective informed consent
- •Subject agrees to comply with all study procedures
排除标准
- •Kidney donor is an identical twin of the subject.
- •The subject has another previously transplanted organ in situ.
- •Subject has received a hematopoietic stem cell transplant.
- •Subject has received a bone marrow graft.
- •Subject has self-reported as pregnant.
- •In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.
- •Sample Inclusion Criteria:
- •1. A graft biopsy is obtained within ±1 week of blood draw.
- •If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.
- •Sample Exclusion Criteria:
- •Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
- •Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
- •Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
- •Sample collected from a subject that provided another sample for the study within the past 7 days.
结局指标
主要结局
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
时间窗: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for Positive Predictive Value (PPV) is 49%.
次要结局
- ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection.(This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.)
- Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen).(This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.)