A Study to Evaluate Patient Outcomes From the Kidney Allograft Outcomes AlloSure® Registry (KOAR)

Overview

About this study

The purpose of this study is 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®.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

AlloSure Test 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 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.
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.

Exclusion Criteria:

Pregnant at the time of blood draw.
The recipient of an organ from a monozygotic (identical) twin sibling.
Have multiple transplanted organs.
Have received an allogeneic blood or bone marrow transplant.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Hani Wadei, M.D.	Closed for enrollment	Contact information: FL General Clinical Studies Unit (GCSU) (904) 953-2255

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Wadei, M.D.

Closed for enrollment

Contact information:

FL General Clinical Studies Unit (GCSU)

(904) 953-2255

More information

Publications

Publications are currently not available

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