Clinical Trial

Kidney Allograft Outcomes AlloSure Registry

Study Description

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 AlloSureAR. AlloSureAR 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 KidneyCareAR.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Diagnostic Test - Donor-derived cell-free DNA (AlloSure®)

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.

Standard care

Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)

Diagnostic Test - Peripheral blood gene expression profiling (AlloMap Kidney)

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.

Diagnostic Test - Analytic platform (IBox)

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.

Additional Information

Official Study Title

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

Clinical Trial ID

NCT03326076

ParticipAid ID

RdGlQe