Status:
UNKNOWN
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
Lead Sponsor:
CareDx
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
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 meas...
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....
Eligibility Criteria
Inclusion
- KOAR
- 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
- \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
- 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
Key Trial Info
Start Date :
January 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT03326076
Start Date
January 23 2018
End Date
December 31 2025
Last Update
June 27 2023
Active Locations (72)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Loma Linda Medical Center
Loma Linda, California, United States, 92354
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90043
4
University of Southern California
Los Angeles, California, United States, 90089