Assessment of QSant™ for Underlying Allograft Rejection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QSant-TM Urine Test.
- Who it may be relevant to
- Registry conditions: Kidney Transplant Failure and Rejection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)
Overview
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.
Interventions
- 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.
Primary outcome measures
- QScore specificity and sensitivity in relation to kidney biopsy [Time frame: 6 weeks before each biopsy-proven rejection (BPAR)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Inability to provide a voided urine sample per collection protocol
- Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05282966 · NEPHRO-001