Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
- Conditions
- Kidney Transplant Rejection
- Registration Number
- NCT03326076
- Lead Sponsor
- CareDx
- 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®.
- 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. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- 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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12 months post-transplant in AlloSure® and renal allograft biopsy managed patients Feb-2020 Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies Feb-2020
- Secondary Outcome Measures
Name Time Method Patient and graft survival Dec-2022 Evaluated at years 1, 2, and 3 post-transplant
Serum creatinine Dec-2022 Evaluated at years 1, 2, and 3 post-transplant
Estimated glomerular filtration rate Dec-2022 Evaluated at years 1, 2, and 3 post-transplant
Sensitivity of AlloSure for active rejection Dec-2022 Transplant glomerulopathy (TG) Dec-2022 Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)
Specificity of AlloSure for active rejection Dec-2022 Negative Predictive Value (NPV) of AlloSure for active rejection Dec-2022 Positive Predictive Value (PPV) of AlloSure for active rejection Dec-2022 Develop and validate the clinical use of KidneyCare® Dec-2022
Related Research Topics
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Trial Locations
- Locations (72)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Scroll for more (62 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States