Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    4000
  • sponsor
    CareDx
Updated on 18 June 2021
kidney transplant
gene expression
cfdna
kidney biopsy

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.

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.

Details
Condition Renal Transplant Rejection, Kidney Transplant Rejection
Treatment Standard Care, Donor-derived cell-free DNA (AlloSure®), Peripheral blood gene expression profiling (AlloMap Kidney), Analytic platform (IBox)
Clinical Study IdentifierNCT03326076
SponsorCareDx
Last Modified on18 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Subjects willing to provide written informed consent to participate

Exclusion Criteria

Exclusions for AlloSure Intended Use
Specimens from patients for whom any of the following are true will not be
tested
Recipients of transplanted organs other than kidney
Recipients of a transplant from a monozygotic (identical)
Recipients of a bone marrow transplant
Recipients who are pregnant
Recipients who are under the age of 18
Recipient who are less than 14 days post-transplant
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