Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
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.
- Kidney Transplant Rejection
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- 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
- Study Type
- Observational Model
- Time Perspective
|Primary donor-derived cell-free DNA||300 patients with planned renal surveillance biopsies at 12 months post-transplantation||
|Control||A matched control cohort of 300 patients with planned renal surveillance biopsies at 12 months post-transplantation but were not managed with donor-derived cell-free DNA (AlloSure®) will be retrospectively selected||
|Secondary donor-derived cell-free DNA||700 patients without planned renal surveillance biopsies at 12 months post-transplantation||
- NCT ID
Study ContactSham Dholakia
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.