Clinical Trial Title
Evaluation of Patient Outcomes from the Kidney Care on Renal Allografts RegistryNational Clinical Trial Number:
NCT03326076Contact Information
Clinical Trial Protocol Description:
The primary safety objective is to test the hypothesis that a strategy of monitoring for rejection that introduces AlloSure® into clinical practice does not lead to inferior renal allograft outcomes when compared to a strategy of monitoring for rejection that does not include AlloSure.
The primary efficacy objective is to test the hypothesis that a strategy of monitoring for rejection that introduces AlloSure into clinical practice results in a reduction in the number of renal biopsies performed when compared to a strategy of clinical care without the use of AlloSure.
Amendment 1 (A1): The secondary efficacy objective is to develop and validate the clinical use of KidneyCare®.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- AlloSure Test Cohort: Single de-novo or repeat renal transplant recipients selec
ted by their providers to receive AlloSure testing as part of their practical care (deemed medically necessary) beginning within 2 months post-transplant. - KidneyCare Cohort: Single de-novo or repeat renal transplant recipients selected by their providers to receive AlloSure testing as part of their practical care (deemed medically necessary) beginning within 4 months post-transplant.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.