Prospective Assessment of Rejection in Kidney Transplant (PARK)

NephroSant

Status: Enrolling

Conditions: Kidney Transplant Failure and Rejection

Treatments: Other: QSant

Study type: Observational

Funder types: Industry

Identifiers

NCT05715853

NEPHRO-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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