Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:
Shiang-Cheng Kung

Description

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.

Details

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.

Keywords

Kidney Transplant Rejection Donor-derived cell-free DNA (AlloSure®) Standard care Secondary donor-derived cell-free DNA

Eligibility

For people ages 18 years and up

KOAR 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.

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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center accepting new patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CareDx
Links
Bromberg JS, et al. Biological Variation of Donor-derived Cell-free DNA in Renal Transplant Recipients. The Journal of Applied Laboratory Medicine. (2017)
ID
NCT03326076
Lead Scientist
Shiang-Cheng Kung
Study Type
Observational
Last Updated