Kidney Transplant Failure and RejectionAQUANCT05282966
Assessment of QSant™ for Underlying Allograft Rejection
An observational study of Kidney Transplant Failure and Rejection, run by NephroSant.
Trial summary
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- QSant-TM Urine Test
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Oct 2026
- How long will I take part?
- 24 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplant recipients of all ages
Who may be able to join
- Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney 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 augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.
Read the detailed description
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. Each participant will be tracked for 24 months. QSant testing will be performed according to the intended use guidelines specified in "LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (SCr/eGFR) as described in the study schedule. Participants will be compared to a site-specific retrospective cohort of KTRs without QSant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from UNOS (United Network for Organ Sharing) data.
- Conditions
- Kidney Transplant Failure and Rejection
- Being tested
- QSant-TM Urine Test
- Keywords
- kidney transplant, kidney biopsy, allograft rejection, subclinical allograft rejection, kidney, kidney health, kidney function, urine sample, urine test, kidney disease
- Medical subject headings
- Rejection, Psychology, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QSant-TM Urine TestDiagnostic test
Also called QSant(TM), QScore(TM)
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort with QSant Testing | 2,000 participants will be enrolled across sites within 90-days post-kidney transplant and followed for 24-months Receives: Diagnostic Test: QSant-TM Urine Test | |
| Retrospective Control Cohort without QSant Testing | 2,000 site-matched controls from UNOS database who underwent a kidney transplant no more than 5 years prior to the study completion date |
What is being measured
The primary outcome is the main question the study is designed to answer.
QScore specificity and sensitivity in relation to kidney biopsy
Demonstrate sensitivity and specificity of QSant for detecting biopsy-proven rejection (BPAR), defined as t-score ≥1. For this aim QSant detection will be based on a threshold of >32 within 6 weeks of BPAR (using the most recently collected result)
Measured: 6 weeks before each biopsy-proven rejection (BPAR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study startMar 2023 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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
- 4,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- NephroSant
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282966
- Sponsor's protocol ID
- NEPHRO-001
- Acronym
- AQUA
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2022
- Last updated
- 28 Sep 2022
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)
- ClinicalTrials.gov ID
- NCT05282966
- Acronym / sponsor ID
- AQUA / NEPHRO-001
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- kidney transplant, kidney biopsy, allograft rejection, subclinical allograft rejection, kidney, kidney health, kidney function, urine sample
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- NephroSantIndustry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Mar 2022 (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 AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.
Detailed description
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. Each participant will be tracked for 24 months. QSant testing will be performed according to the intended use guidelines specified in "LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (SCr/eGFR) as described in the study schedule. Participants will be compared to a site-specific retrospective cohort of KTRs without QSant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from UNOS (United Network for Organ Sharing) data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort with QSant Testing | – | Diagnostic Test: QSant-TM Urine Test2,000 participants will be enrolled across sites within 90-days post-kidney transplant and followed for 24-months |
| Retrospective Control Cohort without QSant Testing | – | –2,000 site-matched controls from UNOS database who underwent a kidney transplant no more than 5 years prior to the study completion date |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant recipients of all ages
Key inclusion criteria (3 listed)
- Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney 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 (2 listed)
- Inability to provide a voided urine sample per collection protocol
- Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.
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 |
|---|---|---|
| QSant-TM Urine TestAlso: QSant(TM), QScore(TM)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. | Diagnostic test | Prospective Cohort with QSant Testing |
Primary outcome
QScore specificity and sensitivity in relation to kidney biopsy
Time frame: 6 weeks before each biopsy-proven rejection (BPAR)
Demonstrate sensitivity and specificity of QSant for detecting biopsy-proven rejection (BPAR), defined as t-score ≥1. For this aim QSant detection will be based on a threshold of >32 within 6 weeks of BPAR (using the most recently collected result)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure and Rejection, run by NephroSant.
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 3 inclusion and 2 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Director of Clinical Affairs (650-781-6337, registrysupport@nephrosant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QScore specificity and sensitivity in relation to kidney biopsy (time frame: 6 weeks before each biopsy-proven rejection (BPAR)). 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 28 Sep 2022.