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

NCT07751913 | Not Yet Recruiting FDA Device

• 1 other identifier: TD-0790
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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

Acute Kidney Injury

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  From T0 specimen collection through assessment of acute kidney injury status at 72 hours after ICU admission

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU 22 years of age and older

You may qualify if:

• 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

You may not qualify if:

• 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; or 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.

Sponsors & Collaborators

• BioPorto Diagnostics: lead

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and plasma

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08