Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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®.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
KOAR Inclusion Criteria:
1. 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.
2. 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:
1. Recipients of transplanted organs other than kidney
2. Recipients of a transplant from a monozygotic (identical)
3. Recipients of a bone marrow transplant
4. Recipients who are pregnant
5. Recipients who are under the age of 18
6. Recipient who are less than 14 days post-transplant
Accepts Healthy Volunteers
Call +1 (305) 3555418