Assessment of QSant™ for Underlying Allograft Rejection

Kidney Transplant Failure and Rejection Clinical Trial

— AQUA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05282966
• Other study ID #: NEPHRO-001
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: October 2026

Study information

• Verified date: September 2022
• Source: NephroSant
• Contact: Director of Clinical Affairs
• Phone: 650-781-6337
• Email: registrysupport[@]nephrosant.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Failure and Rejection

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NephroSant

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)