Kidney Transplant Failure and Rejection
Conditions
Keywords
kidney transplant, kidney biopsy, allograft rejection
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.
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).
Interventions
OTHERQSant
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.
Sponsors
NephroSant
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect coincident urine specimens and biopsy results from participants | Prior to biopsy | Collect urine sample using QSant kit for adult kidney transplant recipients |
| QScore specificity and sensitivity in relation to kidney biopsy | Prior to biopsy | Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy |
Countries
United States
Contacts
Primary ContactSr. Director of Clinical Affairs
Outcome results
None listed