The PARK study is a multi-center observational study to assess the performance of the QSant test with kidney biopsy. QSant is a test based on 6 urinary biomarkers that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection.
Non-randomized, unblinded observational study to collect urine samples, coincident allograft biopsy results, and relevant clinical data to evaluate the QSant test. Participants will be recruited prior to or on the day of an already scheduled kidney biopsy. Urine samples will be collected before biopsy (protocol and for-cause).
Study Type
OBSERVATIONAL
Enrollment
1,000
QSant™ is a needle free urine test collected in-home or in-clinic to aid in the evaluation and management of kidney transplant recipients' allograft status. QSant evaluates 6 kidney-specific biomarkers.
Intermountain Medical Center
Murray, Utah, United States
RECRUITINGCollect coincident urine specimens and biopsy results from participants
Collect urine sample using QSant kit for adult kidney transplant recipients
Time frame: Prior to biopsy
QScore specificity and sensitivity in relation to kidney biopsy
Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy
Time frame: Prior to biopsy
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