Assessment of QSant™ for Underlying Allograft Rejection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNephroSant

About this trial

The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.

Eligibility criteria

Qualifiers

Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant.

Able to understand risks and requirements of participation and provide informed consent

Willing and able to comply with the study requirements

Disqualifiers

Inability to provide a voided urine sample per collection protocol

Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.

Trial design

Treatments tested in this trial

  • QSant-TM Urine Test

Treatment groups

4,000 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators