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SN-C-00010 Evaluation of Patient Outcomes from the Kidney Allograft Outcomes Registry

NCT03326076

Evaluation of Patient Outcomes from the Kidney Allograft Outcomes Registry

Associated Conditions

Renal

Principal Investigator

Sponsor

CareDx

The primary purpose of this registry is to evaluate patient outcomes in kidney transplant recipients who undergo regular use of KidneyCare testing. KidneyCare is a panel test that includes 3 components: 1. AlloSure Kidney 2. AlloMap Kidney 3. iBox. The AlloSure Kidney test is clinically validated and approved by Medicare for coverage in clinical use when a physician determines there is a need to assess the probability of allograft rejection in kidney transplant recipients. AlloMap Kidney is a research gene expression test using peripheral blood to establish immune activation and is currently undergoing clinical evaluation and development. iBox is an analytic platform that predicts how well your organ will be surviving at 3, 5, 7 and 10 years after transplant using a software algorithm based on information from your medical records. The AlloMap Kidney and iBox components of KidneyCare will not be used for patient management or to make active clinical decisions as part of this study. This registry will provide information on observed outcomes in patients who undergo monitoring for rejection using KidneyCare in clinical practice compared to outcomes in patients who undergo monitoring for rejection that does not include KidneyCare or AlloSure testing alone. These outcomes include the number of biopsies performed and the incidence and severity of rejection.
The registry will collect medical information related to your kidney transplant care (medications, diagnoses, and other information in your medical record), storing that information in a database, and using that information to answer specific research questions.

Researchers will collect select information from your health care records for up to 3 years following the date of your kidney transplant.

This study is currently enrolling.