Kidney Transplant Failure and RejectionPARKNCT05715853
Prospective Assessment of Rejection in Kidney Transplant (PARK)
An observational study of Kidney Transplant Failure and Rejection, run by NephroSant at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- QSant
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult kidney transplant recipients
Who may be able to join
- Kidney transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
- Kidney biopsy scheduled on a date > 14 days post-transplant
- Able to understand risks and requirements of participation and provide informed consent
- Willing and able to comply with the study requirements
Who cannot join
- Inability to provide a voided urine sample per collection protocol
- Urological abnormalities such as catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
- History of or current multi-organ transplant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Sanjiv Anand, MD
About this study
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.
Read the 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
- Kidney Transplant Failure and Rejection
- Being tested
- QSant
- Keywords
- kidney transplant, kidney biopsy, allograft rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QSantOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect coincident urine specimens and biopsy results from participants
Collect urine sample using QSant kit for adult kidney transplant recipients
Measured: Prior to biopsy
QScore specificity and sensitivity in relation to kidney biopsy
Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy
Measured: Prior to biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Dec 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NephroSant
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715853
- Sponsor's protocol ID
- NEPHRO-002
- Acronym
- PARK
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Rejection in Kidney Transplant (PARK)
- ClinicalTrials.gov ID
- NCT05715853
- Acronym / sponsor ID
- PARK / NEPHRO-002
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- kidney transplant, kidney biopsy, allograft rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- NephroSantIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney transplant recipients
Key inclusion criteria (4 listed)
- Kidney transplant recipient ≥ 18 years who are scheduled for kidney biopsy.
- Kidney biopsy scheduled on a date > 14 days post-transplant
- Able to understand risks and requirements of participation and provide informed consent
- Willing and able to comply with the study requirements
Key exclusion criteria (3 listed)
- Inability to provide a voided urine sample per collection protocol
- Urological abnormalities such as catheters, augmented bladder, ileal conduits, mitrofanoff, and vesicostomy
- History of or current multi-organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QSantQSant™ 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. | Other | – |
Primary outcome
Collect coincident urine specimens and biopsy results from participants
Time frame: Prior to biopsy
Collect urine sample using QSant kit for adult kidney transplant recipients
QScore specificity and sensitivity in relation to kidney biopsy
Time frame: Prior to biopsy
Evaluate the QSant algorithm performance in terms of sensitivity, specificity, and accuracy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure and Rejection, run by NephroSant at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sr. Director of Clinical Affairs ((833) 697-7268, research@nephrosant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect coincident urine specimens and biopsy results from participants (time frame: Prior to biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.