Trials / Unknown
UnknownNCT05715853
Prospective Assessment of Rejection in Kidney Transplant (PARK)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- NephroSant · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2022-12-20
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
- First posted
- 2023-02-08
- Last updated
- 2023-02-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05715853. Inclusion in this directory is not an endorsement.