Acute Kidney InjuryNCT05271617
VIDAS Nephroclear (NCL) CCL14 - Sample Stability
An observational study of Acute Kidney Injury, run by BioMérieux at 1 site in United States.
Trial summary
This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability conditions for the VIDAS® NEPHROCLEAR™ CCL14 Test. 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?
- VIDAS® NEPHROCLEAR™ CCL14
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 31 Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), who qualify based on the criteria described above. These participants are recruited under a separate protocol IRB approved protocol. This protocol covers testing of leftover samples only.
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); (NOTE: HIV or hepatitis testing will not be performed for enrollment in this study.)
- Special populations, pregnant women, prisoners or institutionalized individuals;
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: VIDAS Nephroclear CCL14 : Sample Stability Study
This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability conditions for the VIDAS® NEPHROCLEAR™ CCL14 Test. This test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
Read the detailed description
Product name and intended use
The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
Product description
The VIDAS® NEPHROCLEAR™ CCL14 Test is an automated assay for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of C-C motif chemokine ligand 14 (CCL14) protein in human urine using the Enzyme Linked Fluorescent Assay (ELFA) technique.
Trial Design Overview
This VIDAS® NEPHROCLEAR™CCL14 (VIDAS® NCL™ CCL14) clinical trial is a multicenter, prospective, and qualitative study. 40 to 80 samples collected and tested from subjects enrolled in a related trial will also be tested on the VIDAS® 3 instrument and test.
Trial objectives
The objective of this trial is to identify suitable storage conditions for samples tested using the VIDAS® NCL™ CCL14 for the full measuring range of the assay (0.2 ng/mL to 30 ng/mL). To this end, samples will be tested under the following conditions:
- Fresh, and tested within approximately 2 hours of collection,
- After one freeze-thaw cycle,
- After two freeze-thaw cycles,
- After storage at ambient temperature for approximately 5 hours (tested 5 to 7 hours from collection time), and
- After storage at 2 - 8 ºC for approximately 24 hours (tested 24 to 26 hours from collection time)
Samples collected from at least 40 subjects with urine CCL14 levels spanning the assay measuring range will be analyzed among these conditions.
- Conditions
- Acute Kidney Injury
- Being tested
- VIDAS® NEPHROCLEAR™ CCL14
- 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.
VIDAS® NEPHROCLEAR™ CCL14Diagnostic test
Measurement of CCL14 in sample aliquots after being subjected to different testing conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample stability conditions
Detection of CCL14 levels in urine, spanning the measuring range of the assay for several sample conditions.
Measured: one sample will be collected per participant, aliquots will be tested at various conditions: fresh, after one to two freeze-thaw cycles, after refrigeration for 24 hours and after 6 hours at room temperature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start10 Mar 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271617
- Sponsor's protocol ID
- B3166-CTPR01
- Status last verified
- Sep 2023
- First submitted
- 28 Feb 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIDAS Nephroclear CCL14 : Sample Stability Study
- ClinicalTrials.gov ID
- NCT05271617
- Acronym / sponsor ID
- B3166-CTPR01
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 9 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.
This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability conditions for the VIDAS® NEPHROCLEAR™ CCL14 Test. This test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
Detailed description
Product name and intended use
The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
Product description
The VIDAS® NEPHROCLEAR™ CCL14 Test is an automated assay for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of C-C motif chemokine ligand 14 (CCL14) protein in human urine using the Enzyme Linked Fluorescent Assay (ELFA) technique.
Trial Design Overview
This VIDAS® NEPHROCLEAR™CCL14 (VIDAS® NCL™ CCL14) clinical trial is a multicenter, prospective, and qualitative study. 40 to 80 samples collected and tested from subjects enrolled in a related trial will also be tested on the VIDAS® 3 instrument and test.
Trial objectives
The objective of this trial is to identify suitable storage conditions for samples tested using the VIDAS® NCL™ CCL14 for the full measuring range of the assay (0.2 ng/mL to 30 ng/mL). To this end, samples will be tested under the following conditions:
- Fresh, and tested within approximately 2 hours of collection,
- After one freeze-thaw cycle,
- After two freeze-thaw cycles,
- After storage at ambient temperature for approximately 5 hours (tested 5 to 7 hours from collection time), and
- After storage at 2 - 8 ºC for approximately 24 hours (tested 24 to 26 hours from collection time)
Samples collected from at least 40 subjects with urine CCL14 levels spanning the assay measuring range will be analyzed among these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 moderate to severe (stage 2 or 3) acute kidney injury (AKI), who qualify based on the criteria described above. These participants are recruited under a separate protocol IRB approved protocol. This protocol covers testing of leftover samples only.
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); (NOTE: HIV or hepatitis testing will not be performed for enrollment in this study.)
- 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 |
|---|---|---|
| VIDAS® NEPHROCLEAR™ CCL14Measurement of CCL14 in sample aliquots after being subjected to different testing conditions | Diagnostic test | – |
Primary outcome
Sample stability conditions
Time frame: one sample will be collected per participant, aliquots will be tested at various conditions: fresh, after one to two freeze-thaw cycles, after refrigeration for 24 hours and after 6 hours at room temperature
Detection of CCL14 levels in urine, spanning the measuring range of the assay for several sample conditions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BioMérieux 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: finished, as of the sponsor's last update on 11 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample stability conditions (time frame: one sample will be collected per participant, aliquots will be tested at various conditions: fresh, after one to two freeze-thaw cycles, after refrigeration for 24 hours and after 6 hours at room temperature). 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 11 Sep 2023.