Acute Kidney InjuryALPACANCT07751913
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
An observational study of Acute Kidney Injury, run by BioPorto Diagnostics at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission. 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
- 4 sitesUnited States
- Study dates
- 21 Jul 2026to May 2028
- 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
- Males and females ≥ 22 years of age. Subjects must be admitted or admission pending 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 (unless otherwise specified):
- Vasoactive medication administration Mechanical ventilation Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula Serum Lactate greater than 2.5 mmol/L, within 6 hours prior to enrollment History (any) of solid organ transplantation, renal transplantation included only if more than 3 months prior History (any) of bone marrow transplantation Ability to provide written 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 or 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73m2.
- Subjects with any known urothelial, urological or kidney malignancies.
- Subjects that have had any of the following urologic procedure or urologic surgery within 30 days prior to ICU admission:
- Nephrostomy or nephroureteral stent placement Ureteral stent placement or exchange Ureteroscopy Lithotripsy Transurethral resection of the prostate Transurethral resection of bladder tumor Renal biopsy Subjects that have had surgical nephrectomy less than 3 months prior to admission.
- Subjects that have been previously enrolled in this study. Subjects enrolled in an interventional pharmaceutical or device clinical trial ICU admission.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of New Mexico
Albuquerque, New Mexico, 87131
The University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Yale University
New Haven, Connecticut, 06510
About this study
Official title: Validation of the ProNephro AKITM (NGAL) in Adult ICU Patients in the ICU at Risk of Moderate to Severe Acute Kidney Injury (ALPACA)
The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission.
The study will assess how accurately the test predicts acute kidney injury by evaluating its sensitivity, specificity, positive predictive value, and negative predictive value. Participants will provide blood and urine samples for testing.
- Conditions
- Acute Kidney Injury
- Being tested
- ProNephro AKI™ (NGAL)
- 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.
Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants with independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration of 172 ng/mL or greater, as measured using the ProNephro AKI™ assay.
Measured: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Specificity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration below 172 ng/mL, as measured using the ProNephro AKI™ assay.
Measured: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Positive Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants with a T0 urinary NGAL concentration of 172 ng/mL or greater who have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay.
Measured: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Negative Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants with a T0 urinary NGAL concentration below 172 ng/mL who do not have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay.
Measured: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Secondary outcomes (4)
Correlation Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay
Pearson's r correlation coefficient for paired urinary and plasma NGAL concentrations measured in ng/mL at the same protocol-defined collection time points.
Measured: Across protocol-defined collection time points through 72 hours after ICU admission
Agreement Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay
Agreement between paired urinary and plasma NGAL concentrations measured in ng/mL at the same protocol-defined collection time points will be assessed using Passing-Bablok regression.
Measured: Across protocol-defined collection time points through 72 hours after ICU admission
Change in Urinary NGAL Concentration Over Time by KDIGO Stage 2/3 Acute Kidney Injury Status
Change in urinary NGAL concentration, measured in ng/mL using the ProNephro AKI™ assay, will be evaluated over the protocol-defined collection time points and summarized separately for participants with and without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury.
Measured: From T0 specimen collection through 72 hours after ICU admission
Percentage of Participants Developing KDIGO Stage 2/3 Acute Kidney Injury by Sequential Urinary NGAL Pattern
Percentage of participants who develop independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury, summarized according to sequential urinary NGAL patterns at T0 and T1: negative to negative, negative to positive, positive to positive, and positive to negative. Positive or negative NGAL status will be determined using the 172 ng/mL cut-off.
Measured: From T0 specimen collection through assessment of acute kidney injury status at 72 hours 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 posted7 Aug 2026
- Study start21 Jul 2026
- Primary completionNov 2027 (estimated)
- Study completionMay 2028 (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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioPorto Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosa Canler, Study director, BioPorto Diagnostics A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751913
- Sponsor's protocol ID
- TD-0790
- Acronym
- ALPACA
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The sponsor has not yet determined whether individual participant data will be made available. The data-sharing plan is under evaluation and may be updated as the study progresses.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the ProNephro AKITM (NGAL) in Adult ICU Patients in the ICU at Risk of Moderate to Severe Acute Kidney Injury (ALPACA)
- ClinicalTrials.gov ID
- NCT07751913
- Acronym / sponsor ID
- ALPACA / TD-0790
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- BioPorto DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 7 Aug 2026 (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 study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission.
The study will assess how accurately the test predicts acute kidney injury by evaluating its sensitivity, specificity, positive predictive value, and negative predictive value. Participants will provide blood and urine samples for testing.
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 (3 listed)
- Males and females ≥ 22 years of age. Subjects must be admitted or admission pending 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 (unless otherwise specified):
- Vasoactive medication administration Mechanical ventilation Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula Serum Lactate greater than 2.5 mmol/L, within 6 hours prior to enrollment History (any) of solid organ transplantation, renal transplantation included only if more than 3 months prior History (any) of bone marrow transplantation Ability to provide written informed consent
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 or 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73m2.
- Subjects with any known urothelial, urological or kidney malignancies.
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
Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Percentage of evaluable participants with independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration of 172 ng/mL or greater, as measured using the ProNephro AKI™ assay.
Specificity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Percentage of evaluable participants without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration below 172 ng/mL, as measured using the ProNephro AKI™ assay.
Positive Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Percentage of evaluable participants with a T0 urinary NGAL concentration of 172 ng/mL or greater who have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay.
Negative Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Percentage of evaluable participants with a T0 urinary NGAL concentration below 172 ng/mL who do not have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay.
4 secondary outcomes
Correlation Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay
Time frame: Across protocol-defined collection time points through 72 hours after ICU admission
Agreement Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay
Time frame: Across protocol-defined collection time points through 72 hours after ICU admission
Change in Urinary NGAL Concentration Over Time by KDIGO Stage 2/3 Acute Kidney Injury Status
Time frame: From T0 specimen collection through 72 hours after ICU admission
Percentage of Participants Developing KDIGO Stage 2/3 Acute Kidney Injury by Sequential Urinary NGAL Pattern
Time frame: From T0 specimen collection through assessment of acute kidney injury status at 72 hours 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 29 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The sponsor has not yet determined whether individual participant data will be made available. The data-sharing plan is under evaluation and may be updated as the study progresses.
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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.
Rosa Canler study director
BioPorto Diagnostics A/S
4 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 4 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 3 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off (time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission). The study lists 4 primary outcomes in all. 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 29 Oct 2026.