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®.
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.
Study Type
OBSERVATIONAL
Enrollment
4,000
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
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
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
Time frame: Feb-2020
Total number of biopsies planned and performed post-transplant, including both surveillance and clinically indicated biopsies
Time frame: Feb-2020
Transplant glomerulopathy (TG)
Evaluated at one-year post-transplant, quantified by biopsy-based histopathology grade(s)
Time frame: Dec-2022
Patient and graft survival
Evaluated at years 1, 2, and 3 post-transplant
Time frame: Dec-2022
Serum creatinine
Evaluated at years 1, 2, and 3 post-transplant
Time frame: Dec-2022
Estimated glomerular filtration rate
Evaluated at years 1, 2, and 3 post-transplant
Time frame: Dec-2022
Sensitivity of AlloSure for active rejection
Time frame: Dec-2022
Specificity of AlloSure for active rejection
Time frame: Dec-2022
Negative Predictive Value (NPV) of AlloSure for active rejection
Time frame: Dec-2022
Positive Predictive Value (PPV) of AlloSure for active rejection
Time frame: Dec-2022
Develop and validate the clinical use of KidneyCare®
Time frame: Dec-2022
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 62 more locations