Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CareDx
- 入组人数
- 4,000
- 试验地点
- 72
- 主要终点
- Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12 months post-transplant in AlloSure® and renal allograft biopsy managed patients
研究概览
简要总结
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.
Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
详细描述
The AlloSure test has been approved for Medicare coverage for clinical use when a physician determines there is a need to assess the probability of allograft rejection in kidney transplant recipients. The DART study suggests that use of the non-invasive AlloSure test to measure donor-derived cell-free DNA (dd-cfDNA) can be used to discriminate active rejection in a renal transplant recipient. Use of the test may reduce invasive percutaneous renal biopsy procedures among patients with a suspicion of rejection.
Amendment 1 (A1) is intended to enable the development of KidneyCare® which is a panel test which includes the clinically validated commercial AlloSure dd-cfDNA test, combined with AlloMap Kidney which is a peripheral blood gene expression profiling test currently under development, and iBox, which is an analytic platform that predicts allograft survival at 3, 5, 7 and 10 years using a proprietary software algorithm based on a number of clinical inputs. The AlloMap Kidney and the iBox components are not yet clinically validated and so will not be used for patient management and are being developed through this study.
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
- 是
入选标准
- •Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
- •Subjects willing to provide written informed consent to participate.
排除标准
- •___________________________________________________________
- •Exclusions for AlloSure® Intended Use
- •Specimens from patients for whom any of the following are true will not be tested:
- •Recipients of transplanted organs other than kidney
- •Recipients of a transplant from a monozygotic (identical)
- •Recipients of a bone marrow transplant
- •Recipients who are pregnant
- •Recipients who are under the age of 18
- •Recipient who are less than 14 days post-transplant
结局指标
主要结局
Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12 months post-transplant in AlloSure® and renal allograft biopsy managed patients
时间窗: Feb-2020
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies
时间窗: Feb-2020
次要结局
- Sensitivity of AlloSure for active rejection(Dec-2022)
- Patient and graft survival(Dec-2022)
- Serum creatinine(Dec-2022)
- Estimated glomerular filtration rate(Dec-2022)
- Transplant glomerulopathy (TG)(Dec-2022)
- Specificity of AlloSure for active rejection(Dec-2022)
- Negative Predictive Value (NPV) of AlloSure for active rejection(Dec-2022)
- Positive Predictive Value (PPV) of AlloSure for active rejection(Dec-2022)
- Develop and validate the clinical use of KidneyCare®(Dec-2022)