Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT03326076

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

Official Title:

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

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®.

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

Disease(s) and\or Condition(s)

Kidney Transplant Rejection

Primary Purpose
Intervention/Treatment
    • Type: DIAGNOSTIC_TEST
    • Name: Donor-derived cell-free DNA (AlloSure®)
    • Description: Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
    • Arm Group Labels: Primary KidneyCare®, Primary donor-derived cell-free DNA, Secondary KidneyCare®, Secondary donor-derived cell-free DNA
    • Type: OTHER
    • Name: Standard care
    • Description: Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
    • Arm Group Labels: Control
    • Type: DIAGNOSTIC_TEST
    • Name: Peripheral blood gene expression profiling (AlloMap Kidney)
    • Description: Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
    • Arm Group Labels: Primary KidneyCare®, Secondary KidneyCare®
    • Type: DIAGNOSTIC_TEST
    • Name: Analytic platform (IBox)
    • Description: Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
    • Arm Group Labels: Primary KidneyCare®, Secondary KidneyCare®
Sponsor
  • CareDx