Assessment of QSant™ for Underlying Allograft Rejection (AQUA)

NephroSant

Status: Not yet enrolling

Conditions: Kidney Transplant Failure and Rejection

Treatments: Diagnostic Test: QSant-TM Urine Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05282966

NEPHRO-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

4,000 participants in 2 patient groups

Prospective Cohort with QSant Testing

Description:

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

Treatment:

Diagnostic Test: QSant-TM Urine Test

Retrospective Control Cohort without QSant Testing

Description:

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