The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population

Kidney Injury Clinical Trial

Official title:

The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057457
• Other study ID #: NGAL-001
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2017
• Last updated: March 30, 2017
• Start date: March 2017
• Est. completion date: February 2018

Study information

• Verified date: March 2017
• Source: BioPorto Diagnostics
• Contact: Patsy Folio
• Phone: 480-735-9035
• Email: patsy.folio[@]precisionformedicine.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for testing on automated clinical chemistry analyzer.

The First Indication for Use: An NGAL test result above the assay cutoff as an aid in the risk assessment for the development of stage II or III acute kidney injury (AKI) within 1 day of patient assessment in patients in the intensive care unit (ICU) who are hypotensive (MAP<70 mmHg) and/or receiving vasopressor support. Second Indication for Use: In patents with stage II or III AKI, NGAL measurement aids in the risk assessment of the development of persistent (≥2 days) stage 2 or 3 AKI.

The Primary Objective for this clinical trial is to validate that the NGAL test using a cutoff of 140 ng/ml shows clinical performance in predicting the development of moderate or severe acute kidney injury within 1 day. The Secondary Objective is to validate that the NGAL test shows clinical performance in predicting persistent moderate or severe acute kidney injury during any contiguous 2 day interval.

It is anticipated that up to 20 Clinical Sites in US will participate in the trial. The study sites will recruit consecutive patients meeting the inclusion and exclusion criteria who are admitted to hospital in an ICU or critical care setting. Patients will receive their clinical standard of care including standard laboratory and other testing as requested by each subject's physician.

Description:

The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for testing on automated clinical chemistry analyzer.

The First Indication for Use: An NGAL test result above the assay cutoff as an aid in the risk assessment for the development of stage II or III acute kidney injury (AKI) within 1 day of patient assessment in patients in the intensive care unit (ICU) who are hypotensive (MAP<70 mmHg) and/or receiving vasopressor support. Second Indication for Use: In patents with stage II or III AKI, NGAL measurement aids in the risk assessment of the development of persistent (≥2 days) stage 2 or 3 AKI.

The Primary Objective for this clinical trial is to validate that the NGAL test using a cutoff of 140 ng/ml shows clinical performance in predicting the development of moderate or severe acute kidney injury within 1 day. The Secondary Objective is to validate that the NGAL test shows clinical performance in predicting persistent moderate or severe acute kidney injury during any contiguous 2 day interval.

It is anticipated that up to 20 Clinical Sites in the US will participate in the trial. The study sites will recruit consecutive patients meeting the inclusion and exclusion criteria who are admitted to hospital in an ICU or critical care setting. Patients will receive their clinical standard of care including standard laboratory and other testing as requested by each subject's physician. Enrollment is estimated to take approximately six months and the trial will be stopped when the Adjudication Panel has diagnosed at least 85 patients with AKI stage 2 or 3.

Each subject who is enrolled in the study will only have 4 blood draws as part of NGAL TestTM Trial with no additional study activities with the exception of data collection. The NGAL results will not be returned to the treating physician for use in the health management of the study subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Subjects should be enrolled within 24 hrs. of ICU admission, from ED or floor within 24 hrs. of ICU admission or if the subject is from another ICU no more than 24 hrs. from presentation.

• Within 24 hrs. prior to enrollment the subject's

o Cardiovascular SOFA score of >= 1(MAP<70 mmHg and/or receiving any vasopressor support

• Subject or representative written informed consent

• Subject > 18 years of age

Exclusion Criteria:

• If the subject is part of a special population (pregnancy, prisoners)

• If the subject has received a previous renal transplantation

• If the subject has been diagnosed with moderate to severe AKI prior to enrollment as defined by the treating physician (KDIGO Stage 2/3, RIFLE-I or RIFLE-F/AKIN 2 or AKIN 3) ,

• If the subject is currently on dialysis or in imminent need of dialysis at the time of enrollment

• The subject has been diagnosed with HIV or Hepatitis

• The subject has been diagnosed with Chronic Kidney disease without baseline value - CKD stage 4-5

• If the patient is on palliative care

Related Conditions & MeSH terms

• Kidney Injury

Intervention

Device:
• NGAL Test
The purpose of this study is to demonstrate that BioPorto Diagnostic's NGAL test is able to assist in determining the risk for acute kidney injury for patients who have been admitted to the intensive care unit.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Colorado Kidney Care	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
BioPorto Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity	To demonstrate that the sum of sensitivity and specificity is greater than 1 using a cutoff of 140 ng/mL when compared to the primary clinical endpoint AKI as adjudicated KDIGO Stage 2/3 AKI	Up to 7 days in ICU or until discharge