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.

Condition

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 300 patients with planned renal surveillance biopsies at 12 months post-transplantation but were not managed with donor-derived cell-free DNA (AlloSure®) 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 700 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.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Omar Mohammed
347-671-8217
OMOHAMME@montefiore.org

More Details

NCT ID
NCT03326076
Status
Recruiting
Sponsor
CareDx

Study Contact

Quynh Tran
415-287-2309
qtran@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. Accurate and timely detection of allograft rejection and effective treatment are essential for long-term survival of renal transplants. The DART study validated the ability of the non-invasive AlloSure test to measure donor-derived cell-free DNA (dd-cfDNA) to discriminate active rejection in a renal transplant recipient. Use of the test will inform and may reduce invasive percutaneous renal biopsy procedures among patients with risk of rejection.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.