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
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.
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.
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