Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults

NCT06652100 | Active Not Recruiting FDA Device

• 1 other identifier: TD-0475
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Acute Kidney Injury

Keywords

NGAL; ICU; adult

Outcome Measures

Primary Outcomes (1)

• 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.

  24hrs after ICU admission

Secondary Outcomes (1)

• Sub-Group analysis

  24hrs 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:

• 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)
• 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.

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 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

Sponsors & Collaborators

• BioPorto Diagnostics: lead
• ProPharma Group: collaborator

Study Sites (12)

The University of Alabama

Birmingham, Alabama, 35233, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 40802457 DERIVED

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: October 4, 2024
• First Posted: October 22, 2024
• Study Start: October 28, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (12)