Acute Kidney InjuryEPACRA-AKINCT06652100
Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults
An observational study of Acute Kidney Injury, run by BioPorto Diagnostics at 12 sites in United States.
Trial summary
The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- ProNephro AKI (NGAL)
- How many people
- 800 participants
- Where
- 12 sitesUnited States
- Study dates
- 28 Oct 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU 22 years of age and older
Who may be able to join
- Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.
- Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU:
- Vasoactive medication administration
- Mechanical ventilation
- Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula
- Mean arterial pressure (MAP) less than 60 (within 12 hrs. of ICU admission only)
Show all 9Show fewer
- Serum Lactate greater than 2.5 mmol/L
- History of solid organ transplantation, renal transplantation included only if more than 3 months prior
- History of bone marrow transplantation Subject with signed informed consent.
Who cannot join
- Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.
- Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.
- Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.
- Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist.
- Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU.
- Subjects that have had surgical nephrectomy less than 3 months prior to admission.
- Subjects that have been previously enrolled in this study. Subjects that do not have a baseline sCR within 6 months prior to ICU admission available.
- Subjects that did not sign the informed consent. Subjects enrolled in an interventional pharmaceutical or device clinical trial at time of ICU admission
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21224
The University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Yale University
New Haven, Connecticut, 06510
Columbia University
New York, New York, 10032
UC Davis
Sacramento, California, 95817
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)
The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury.
- Conditions
- Acute Kidney Injury
- Being tested
- ProNephro AKI (NGAL)
- Keywords
- NGAL, ICU, adult
- 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.
ProNephro AKI (NGAL)Diagnostic test
ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut off Establishment
The primary objective is to establish the cut-off value for the ProNephro AKI (NGAL) in critically ill adult patients (age 22 and older) admitted to ICU when used as an aid in risk assessment of the development of moderate to severe acute kidney injury (KDIGO stage 2/3) within 48-72 hrs. after admission.
Measured: 24hrs after ICU admission
Secondary outcomes (1)
Sub-Group analysis
Secondary objective is to explore independent cut-offs and estimate performance for NGAL in urine for the following patient subgroups:
Patients after cardiac surgery Patients with decompensating cirrhosis Patients with sepsis Male vs female subjects Sensitivity, specificity, negative and positive predictive values are to be calculated as applicable.
Measured: 24hrs after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start28 Oct 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioPorto Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProPharma Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652100
- Sponsor's protocol ID
- TD-0475
- Acronym
- EPACRA-AKI
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Strader M, Imran S, Tariq A, Fraser C, Saghie E, Louis BC, Meade T, Stoyanov V, Cote JM, Twomey PJ, Murray PT. Clinical Implementation of Urinary Neutrophil Gelatinase-Associated Lipocalin Testing for Diagnosing Acute Kidney Injury in an Academic Tertiary Care Medical Centre. Kidney360. 2025 Dec 1;6(12):2119-2129. doi: 10.34067/KID.0000000887. Epub 2025 Aug 13.
PubMed 40802457
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)
- ClinicalTrials.gov ID
- NCT06652100
- Acronym / sponsor ID
- EPACRA-AKI / TD-0475
- Conditions
- Acute Kidney Injury
- Keywords
- NGAL, ICU, adult
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- BioPorto DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- ProPharma Group
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 Oct 2024 (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 purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU 22 years of age and older
Key inclusion criteria (9 listed)
- Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.
- Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU:
- Vasoactive medication administration
- Mechanical ventilation
- Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula
Key exclusion criteria (8 listed)
- Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.
- Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.
- Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.
- Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist.
- Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU.
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 |
|---|---|---|
| ProNephro AKI (NGAL)ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. | Diagnostic test | – |
Primary outcome
Cut off Establishment
Time frame: 24hrs after ICU admission
The primary objective is to establish the cut-off value for the ProNephro AKI (NGAL) in critically ill adult patients (age 22 and older) admitted to ICU when used as an aid in risk assessment of the development of moderate to severe acute kidney injury (KDIGO stage 2/3) within 48-72 hrs. after admission.
1 secondary outcome
Sub-Group analysis
Time frame: 24hrs after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 40802457Strader M, Imran S, Tariq A, Fraser C, Saghie E, Louis BC, Meade T, Stoyanov V, Cote JM, Twomey PJ, Murray PT. Clinical Implementation of Urinary Neutrophil Gelatinase-Associated Lipocalin Testing for Diagnosing Acute Kidney Injury in an Academic Tertiary Care Medical Centre. Kidney360. 2025 Dec 1;6(12):2119-2129. doi: 10.34067/KID.0000000887. Epub 2025 Aug 13.
- Individual participant dataSharing planned: Undecided
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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.
12 sites 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 BioPorto Diagnostics at 12 sites 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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Cut off Establishment (time frame: 24hrs after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652100, which also lists 1 linked publication.
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 19 Nov 2025.