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

Sponsor
BioPorto Diagnostics
Study ID
NCT07751913
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
800 participants (estimated)

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 ]

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