Acute Kidney InjuryNCT04785391
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test
An observational study of Acute Kidney Injury, run by Astute Medical, Inc. at 1 site in United States.
Trial summary
The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Urine collection for NEPHROCLEAR CCL14 Test
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to Dec 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients with KDIGO stage 2 or 3 AKI.
Who may be able to join
- Males and females 21 years of age or older;
- Receiving care in an intensive care unit;
- Expected to remain in the ICU for at least 48 hours after enrollment;
- Use of indwelling urinary catheter as standard care at the time of enrollment;
- Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
- Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
- Written informed consent provided by patient or legally authorized representative (LAR).
Who cannot join
- Prior kidney transplantation;
- Comfort-measures-only status;
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
- Special populations, pregnant women, prisoners or institutionalized individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Research Coordinator Manager
About this study
The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.
- Conditions
- Acute Kidney Injury
- Being tested
- Urine collection for NEPHROCLEAR CCL14 Test
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection for NEPHROCLEAR CCL14 TestDiagnostic test
Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test
| Study group | Role | What they receive |
|---|---|---|
| Patients with KDIGO stage 2 or 3 AKI | Not described Receives: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
Measured: Within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start8 Jun 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astute Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay L Koyner, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785391
- Sponsor's protocol ID
- Diamond
- Status last verified
- Jul 2022
- First submitted
- 1 Mar 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test
- ClinicalTrials.gov ID
- NCT04785391
- Acronym / sponsor ID
- Diamond
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Astute Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Mar 2021 (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 objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with KDIGO stage 2 or 3 AKI | – | Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients with KDIGO stage 2 or 3 AKI.
Key inclusion criteria (7 listed)
- Males and females 21 years of age or older;
- Receiving care in an intensive care unit;
- Expected to remain in the ICU for at least 48 hours after enrollment;
- Use of indwelling urinary catheter as standard care at the time of enrollment;
- Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
Key exclusion criteria (5 listed)
- Prior kidney transplantation;
- Comfort-measures-only status;
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
- Special populations, pregnant women, prisoners or institutionalized individuals.
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 |
|---|---|---|
| Urine collection for NEPHROCLEAR CCL14 TestUrine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test | Diagnostic test | Patients with KDIGO stage 2 or 3 AKI |
Primary outcome
Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
Time frame: Within 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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.
Jay L Koyner, MD principal investigator
University of Chicago
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 Acute Kidney Injury, run by Astute Medical, Inc. 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 7 inclusion and 5 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 20 Jul 2022. 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 Clinical Trials Manager (858-500-7000, astuteclinical@biomerieux.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication (time frame: Within 5 days). 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 20 Jul 2022.