Assessment of QSant™ for Underlying Allograft Rejection

ConditionKidney Transplant Failure and 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

This trial does not accept healthy volunteers

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 population

Kidney transplant recipients of all ages

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

QSant-TM Urine Test
Diagnostic test
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.

Treatment groups

4,000 Participants

are divided into 2 treatment groups

Group A: Prospective Cohort with QSant Testing1 intervention

Group B: Retrospective Control Cohort without QSant Testing0 interventions

Trial outcomes

Primary outcomes

QScore specificity and sensitivity in relation to kidney biopsy

Demonstrate sensitivity and specificity of QSant for detecting biopsy-proven rejection (BPAR), defined as t-score ≥1. For this aim QSant detection will be based on a threshold of \>32 within 6 weeks of BPAR (using the most recently collected result)

Time frame

6 weeks before each biopsy-proven rejection (BPAR)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NephroSant

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: