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Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
About
Brief Summary
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®.
Study Type
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
KOAR Inclusion Criteria:
- 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 Exclusion Criteria:
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
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Study Stats
Protocol No.
18-001860
Category
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood