Summary

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

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. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

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. 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.

Keywords

Kidney Transplant Rejection Donor-derived cell-free DNA (AlloSure®) Peripheral blood gene expression profiling (AlloMap Kidney) Analytic platform (IBox) Secondary donor-derived cell-free DNA Secondary KidneyCare®

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 in progress, not accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center in progress, not 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
Study Type
Observational
Last Updated