Kidney Transplant Failure and Rejection
Conditions
Keywords
kidney transplant, kidney biopsy, allograft rejection, subclinical allograft rejection, kidney, kidney health, kidney function, urine sample, urine test, kidney disease
Brief 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.
Interventions
DIAGNOSTIC_TESTQSant-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.
Sponsors
NephroSant
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QScore specificity and sensitivity in relation to kidney biopsy | 6 weeks before each biopsy-proven rejection (BPAR) | 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) |
Contacts
Primary ContactDirector of Clinical Affairs
Backup ContactVP of Product Management
Outcome results
None listed