Prospective Assessment of Rejection in Kidney Transplant (PARK)

NCT ID: NCT05715853

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Kidney Transplant Failure and Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NephroSant

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sr. Director of Clinical Affairs

Role: CONTACT

(833) 697-7268

Facility Contacts

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Sanjiv Anand, MD

Role: primary

Other Identifiers

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NEPHRO-002

Identifier Type: -

Identifier Source: org_study_id

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