Kidney Allograft Outcomes AlloSure Registry
common.study.values.description
“Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry”
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSureAR. AlloSureAR 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 KidneyCareAR.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
Diagnostic Test - Donor-derived cell-free DNA (AlloSure®)
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Standard care
Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
Diagnostic Test - Peripheral blood gene expression profiling (AlloMap Kidney)
Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Diagnostic Test - Analytic platform (IBox)
Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
participant.views.study.view.additional
participant.views.study.view.scientific-title
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
common.study.values.clinical-trial-id
NCT03326076
participant.views.study.view.id
RdGlQe
