Recruiting

Kidney Transplant

Sponsor:

NephroSant

Code:

NCT05715853

Conditions

Kidney Transplant Failure and Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QSant

Study Details

Brief summary:

The PARK study is a multi-center observational study to assess the performance of the QSant test with kidney biopsy.

QSant is a test based on 6 urinary biomarkers that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection.

Conditions

Kidney Transplant Failure and Rejection

Study ID

NCT05715853

Start date

Dec 20, 2022

Status verified date

Jan, 2023

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Sep 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Kidney transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
2. Kidney biopsy scheduled on a date > 14 days post-transplant
3. Able to understand risks and requirements of participation and provide informed consent
4. 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 catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
3. History of or current multi-organ transplant

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

QSant

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 measure

  • Collect coincident urine specimens and biopsy results from participants [ Time Frame: Prior to biopsy ]
  • QScore specificity and sensitivity in relation to kidney biopsy [ Time Frame: Prior to biopsy ]

Central Contacts and Locations

Central contacts

Sr. Director of Clinical Affairs

(833) 697-7268research@nephrosant.com

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

More Information

Sponsor

NephroSant

Last update posted

Feb 8, 2023

Last verified

Jan, 2023

Keywords

  • kidney transplant
  • kidney biopsy
  • allograft rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NephroSant on 2023-02-08.