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ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)

NCT07751913 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-08-10

No results posted yet for this study

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.

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

Interventions

DIAGNOSTIC_TEST

ProNephro AKI™ (NGAL)

ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.

Sponsors & Collaborators

  • BioPorto Diagnostics

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-11-30
Completion
2028-05-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751913 on ClinicalTrials.gov