Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry (KOAR)

CareDx

Status: Active, not recruiting

Conditions: Kidney Transplant Rejection

Treatments: Diagnostic Test: Donor-derived cell-free DNA (AlloSure®); Diagnostic Test: Analytic platform (IBox); Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney); Other: Standard care

Study type: Observational

Funder types: Industry

Identifiers

NCT03326076

KOAR

Details and patient eligibility

About

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®.

Full description

The AlloSure test has been approved for Medicare coverage for clinical use when a physician determines there is a need to assess the probability of allograft rejection in kidney transplant recipients. The DART study suggests that use of the non-invasive AlloSure test to measure donor-derived cell-free DNA (dd-cfDNA) can be used to discriminate active rejection in a renal transplant recipient. Use of the test may reduce invasive percutaneous renal biopsy procedures among patients with a suspicion of rejection.

Amendment 1 (A1) is intended to enable the development of KidneyCare® which is a panel test which includes the clinically validated commercial AlloSure dd-cfDNA test, combined with AlloMap Kidney which is a peripheral blood gene expression profiling test currently under development, and iBox, which is an analytic platform that predicts allograft survival at 3, 5, 7 and 10 years using a proprietary software algorithm based on a number of clinical inputs. The AlloMap Kidney and the iBox components are not yet clinically validated and so will not be used for patient management and are being developed through this study.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

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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

Trial design

4,000 participants in 5 patient groups

Primary donor-derived cell-free DNA

Description:

300 patients with planned renal surveillance biopsies at 12 months post-transplantation

Treatment:

Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)

Control

Description:

A matched control cohort of 1000 patients with planned renal surveillance biopsies at 12 months post-transplantation but were not managed with donor-derived cell-free DNA (AlloSure®) or KidneyCare will be retrospectively selected

Treatment:

Other: Standard care

Secondary donor-derived cell-free DNA

Description:

1200 patients without planned renal surveillance biopsies at 12 months post-transplantation

Treatment:

Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)

Primary KidneyCare®

Description:

300 patients with planned renal surveillance biopsies at 12 months post-transplantation

Treatment:

Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney)

Diagnostic Test: Analytic platform (IBox)

Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)

Secondary KidneyCare®

Description:

1200 patients without planned renal surveillance biopsies at 12 months post-transplantation

Treatment:

Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney)

Diagnostic Test: Analytic platform (IBox)

Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)