Prospective Assessment of Rejection in Kidney Transplant (PARK)

• Sponsor: NephroSant (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05715853
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 9.3
• Patients Per Site Per Month: 107.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Failure and Rejection	Other: QSant

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Assessment of Rejection in Kidney Transplant (PARK)
• Actual Study Start Date: Dec 20, 2022
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Outcome Measures

Primary Outcome Measures

1. Collect coincident urine specimens and biopsy results from participants [Prior to biopsy]

   Collect urine sample using QSant kit for adult kidney transplant recipients

2. QScore specificity and sensitivity in relation to kidney biopsy [Prior to biopsy]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intermountain Medical Center	Murray	Utah	United States	84107

Sponsors and Collaborators

• NephroSant

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NephroSant
• ClinicalTrials.gov Identifier: NCT05715853
• Other Study ID Numbers: NEPHRO-002
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NephroSant: kidney transplant; kidney biopsy; allograft rejection

Study Results

No Results Posted as of Feb 8, 2023