Assessment of QSant™ for Underlying Allograft Rejection (AQUA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplant Failure and Rejection
• Intervention / Treatment: Diagnostic test: QSant-TM Urine Test

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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Director of Clinical Affairs; Phone Number: 650-781-6337; Email: registrysupport@nephrosant.com
• Study Contact Backup: Name: VP of Product Management; Phone Number: 833-697-7268; Email: registrysupport@nephrosant.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients of all ages

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Cohort with QSant Testing; 2,000 participants will be enrolled across sites within 90-days post-kidney transplant and followed for 24-months	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.; Other Names: QSant(TM); QScore(TM)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QScore specificity and sensitivity in relation to kidney biopsy	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)	6 weeks before each biopsy-proven rejection (BPAR)

Collaborators and Investigators

• Sponsor: NephroSant

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): October 1, 2026
• Study Completion (ANTICIPATED): October 1, 2026

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (ACTUAL): March 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: kidney disease; kidney; kidney transplant; kidney biopsy; kidney function; allograft rejection; urine test; subclinical allograft rejection; kidney health; urine sample
• Other Study ID Numbers: NEPHRO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No