The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/1/2017 |
| Start Date: | March 2017 |
| End Date: | February 2018 |
| Contact: | Patsy Folio |
| Email: | patsy.folio@precisionformedicine.com |
| Phone: | 480-735-9035 |
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.
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.
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.
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
We found this trial at
2
sites
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