Transition of Renal Patients Using AlloSure Into Community Kidney Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CareDx
- 入组人数
- 248
- 试验地点
- 15
- 主要终点
- Superior allograft survival
研究概览
简要总结
Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA testing at various intervals. The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous, with the potential to improve graft survival and outcomes for transplant patients. The addition of AlloSure to the interventional group will be the focus of this study. Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years.Participants will attend outpatient visits/follow-up visits as part of their standard care, these will include appointments where they will have blood tests taken as part of post-transplant surveillance. For AlloSure cfDNA and DSA, blood will be taken quarterly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with single kidney transplant (de-novo or re-transplant) who are ≥ 6 months and ≤ 36 months post-transplant. Participants and will need to have a draw in this time period .
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 12 years or older.
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
排除标准
- •Participant who is pregnant, lactating or planning pregnancy during the trial.
- •Significant hepatic impairment (determined by the PI).
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- •Participant with life expectancy of less than 6 months, or inappropriate for diagnostic monitoring through regular blood sampling.
- •< 6 months and > 36 months post-transplant
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- •Multi-organ transplant (e.g., Kidney-Pancreas).
结局指标
主要结局
Superior allograft survival
时间窗: 5 years
Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft.
次要结局
- Assessment of kidney function(5 years)
- Assessment of immunologic status(5 years)