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

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ClinicalTrials.gov Identifier: NCT03057457
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
BioPorto Diagnostics

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Kidney Injury Device: NGAL Test

Detailed 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.


Study Design
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Study Type : Observational
Estimated Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Kidney Injury 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.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: Up to 7 days in ICU or until discharge ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intensive care patients diagnosed at high risk for developing AKI.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057457


Contacts
Contact: Patsy Folio 480-735-9035 patsy.folio@precisionformedicine.com
Contact: Natalia Escuti, MD 818 481 2248 natalia.escuti@precisionformedicine.com

Locations
United States, Colorado
Colorado Kidney Care Recruiting
Denver, Colorado, United States, 80218
Contact: Melanie Foster-Schwartz         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Brock Katherine         
Sponsors and Collaborators
BioPorto Diagnostics
More Information
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Responsible Party: BioPorto Diagnostics
ClinicalTrials.gov Identifier: NCT03057457     History of Changes
Other Study ID Numbers: NGAL-001
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No