Open Actively Recruiting

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

About

Brief 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®.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

KOAR 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.

KOAR 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

Join this Trial

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Study Stats
Protocol No.
20-000122
Category
Nephrology
Contact
Janette Gadzhyan
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03326076
For detailed technical eligibility, visit ClinicalTrials.gov.