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CompletedNCT05483088Updated Oct 26, 2023

Urine Sample Processing Study

An observational study in Acute Kidney Injury, sponsored by Astute Medical, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Astute Medical, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
21 Years and older
Sex
All
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Study summary

The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR™ CCL14 Test results. This study is observational and will have no impact on the medical management of the subject.

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Conditions studied

  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's enrollment of 110 is below the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Astute Medical, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult ICU patients with KDIGO stage 2 or 3 AKI.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females 21 years of age or older;
  2. Receiving care in an intensive care unit;
  3. Expected to remain in the ICU for at least 48 hours after enrollment;
  4. Use of indwelling urinary catheter as standard care at the time of enrollment;
  5. Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
  6. Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
  7. Written informed consent provided by patient or legally authorized representative (LAR).

Exclusion criteria

Exclusion Criteria:

  1. Prior kidney transplantation;
  2. Comfort-measures-only status;
  3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
  4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
  5. Special populations, pregnant women, prisoners or institutionalized individuals.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with KDIGO stage 2 or 3 AKI

    Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Interventions

  • Diagnostic testUrine collection for NEPHROCLEAR CCL14 Test

    Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test

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What researchers measure

Primary outcomes

  1. Stability of CCL14 in urine samples

    Stability of CCL14 in urine samples as measured by the NEPHROCLEAR™ CCL14 Test

    Time frame: Up to 24 hours

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Study locations

1 site
  • University of Maryland, Baltimore
    Baltimore, Maryland 21201, United States
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Jul 2023, 20 months.

Of 350 observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2022
First posted
Aug 1, 2022
StartActual
Nov 12, 2021
Primary completionActual
Jul 31, 2023
CompletionActual
Jul 31, 2023
Last update
Oct 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05483088
Lead sponsor
Astute Medical, Inc.
Responsible party
Sponsor
First posted
Aug 1, 2022
Start date
Nov 12, 2021
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Oct 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Astute Medical, Inc.

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