Prospective Assessment of Rejection in Kidney Transplant (PARK) (PARK)

January 27, 2023 updated by: NephroSant

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Non-randomized, unblinded observational study to collect urine samples, coincident allograft biopsy results, and relevant clinical data to evaluate the QSant test.

Participants will be recruited prior to or on the day of an already scheduled kidney biopsy.

Urine samples will be collected before biopsy (protocol and for-cause).

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
          • Sanjiv Anand, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult kidney transplant recipients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect coincident urine specimens and biopsy results from participants
Time Frame: Prior to biopsy
Collect urine sample using QSant kit for adult kidney transplant recipients
Prior to biopsy
QScore specificity and sensitivity in relation to kidney biopsy
Time Frame: Prior to biopsy
Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy
Prior to biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NephroSant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2022

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NEPHRO-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplant Failure and Rejection

Clinical Trials on QSant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe