NCT05715853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

January 27, 2023

Last Update Submit

January 27, 2023

Conditions

Kidney Transplant Failure and Rejection

Keywords

kidney transplantkidney biopsyallograft rejection

Outcome Measures

Primary Outcomes (2)

  • Collect coincident urine specimens and biopsy results from participants

    Collect urine sample using QSant kit for adult kidney transplant recipients

    Prior to biopsy

  • QScore specificity and sensitivity in relation to kidney biopsy

    Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy

    Prior to biopsy

Interventions

QSantOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult kidney transplant recipients

You may qualify if:

  • Kidney transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
  • Kidney biopsy scheduled on a date \> 14 days post-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 catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
  • History of or current multi-organ transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

Sr. Director of Clinical Affairs

CONTACT

(833) 697-7268research@nephrosant.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 8, 2023

Study Start

December 20, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

February 8, 2023

Record last verified: 2023-01

Locations

US(1)