Assessment of QSant™ for Underlying Allograft Rejection

NCT05282966 | Not Yet Recruiting

• 1 other identifier: NEPHRO-001
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplant Failure and Rejection

Keywords

kidney transplant; kidney biopsy; allograft rejection; subclinical allograft rejection; kidney; kidney health; kidney function; urine sample; urine test; kidney disease

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

QSant-TM Urine Test DIAGNOSTIC_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.

Also known as: QSant(TM), QScore(TM)

Prospective Cohort with QSant Testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients of all ages

You may qualify if:

• 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

You may not qualify if:

• Inability to provide a voided urine sample per collection protocol
• Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.

Sponsors & Collaborators

• NephroSant: lead

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Rejection, Psychology; Kidney Diseases

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Director of Clinical Affairs

CONTACT

650-781-6337; registrysupport@nephrosant.com

VP of Product Management

CONTACT

833-697-7268; registrysupport@nephrosant.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 28, 2022

Record last verified: 2022-09