EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)
AlloSure KOAR will recruit eligible kidney recipients who are undergoing AlloSure testing as part of their clinical care to participate in a registry. Patient consent will permit collection and use of data from the patient EMR for entry into the AlloSure database. We will be collecting additional data and outcomes to follow the clinical inquiry and use of AlloSure testing. 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 donorderived 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. Patients may begin use of the AlloSure test 2 weeks following transplantation. The recommended AlloSure testing schedule is at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3 post-transplant. AlloSure testing may also be performed when there is clinical suspicion of rejection or other cause of instability in the allograft to inform on the need for a clinically indicated biopsy. Patients and clinicians may choose to use AlloSure testing as a replacement or pre-test for planned surveillance biopsies to inform on the decision to perform a surveillance biopsy, but not the one-year surveillance biopsy used to generate the primary endpoint data. This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers that do not perform protocol surveillance biopsies. Outcomes in this sub-cohort, which represents the majority of the intended use population in the U.S., will be compared to the outcomes of the test and control cohorts. A matched control cohort of 300 patients will be retrospectively selected from the subset of centers providing the test cohort patients who have planned surveillance biopsies at 12 months post-transplantation.
• 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. KOAR
• 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
Diagnostic Test: Donor-derived cell-free DNA (AlloSure®), Other: Standard care, Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)
Kidney Transplant Rejection
Clinics and Surgery Center (CSC)