NCT05282966

Assessment of QSant™ for Underlying Allograft Rejection

Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: NephroSant · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Kidney Transplant Failure and Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-03-16
• Last updated: 2022-09-28