Assessment of QSant™ for Underlying Allograft Rejection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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. Each participant will be tracked for 24 months. QSant testing will be performed according to the intended use guidelines specified in "LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (SCr/eGFR) as described in the study schedule. Participants will be compared to a site-specific retrospective cohort of KTRs without QSant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from UNOS (United Network for Organ Sharing) data.

Conditions

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Kidney Transplant Failure and Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective Cohort with QSant Testing

2,000 participants will be enrolled across sites within 90-days post-kidney transplant and followed for 24-months

QSant-TM Urine Test

Intervention Type 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.

Retrospective Control Cohort without QSant Testing

2,000 site-matched controls from UNOS database who underwent a kidney transplant no more than 5 years prior to the study completion date

No interventions assigned to this group

Interventions

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QSant-TM Urine 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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QSant(TM) QScore(TM)

Eligibility Criteria

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Inclusion Criteria

1. Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant.
2. Able to understand risks and requirements of participation and provide informed consent
3. Willing and able to comply with the study requirements

Exclusion Criteria

1. Inability to provide a voided urine sample per collection protocol
2. Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.

Eligible Sex

ALL

Accepts Healthy Volunteers

No