Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

Purpose

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®.

Condition

  • Kidney Transplant Rejection

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Medicare-covered (Part B) renal transplant recipients selected by their providers to receive AlloSure testing as part of their practical care beginning by 2 months post-transplantation.
  2. 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.
  3. Subjects willing to provide written informed consent to participate.

KOAR

Exclusion Criteria

  1. Renal transplant recipients without Medicare (Part B) coverage.

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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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Primary donor-derived cell-free DNA 300 patients with planned renal surveillance biopsies at 12 months post-transplantation
  • Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)
    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.
Control 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
  • Other: Standard care
    Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
Secondary donor-derived cell-free DNA 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
  • Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)
    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.
Primary KidneyCare® 300 patients with planned renal surveillance biopsies at 12 months post-transplantation
  • Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)
    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.
  • Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney)
    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.
  • Diagnostic Test: Analytic platform (IBox)
    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.
Secondary KidneyCare® 1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
  • Diagnostic Test: Donor-derived cell-free DNA (AlloSure®)
    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.
  • Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney)
    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.
  • Diagnostic Test: Analytic platform (IBox)
    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.

Recruiting Locations

Tulane University Medical Center
New Orleans, Louisiana 70112
Contact:
Nicole Lassair
504-988-2882
nlassair@tulane.edu

More Details

NCT ID
NCT03326076
Status
Recruiting
Sponsor
CareDx

Study Contact

Sham Dholakia
415-287-2374
sdholakia@caredx.com

Detailed 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.