Kidney InjuryNCT03057457
The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
An observational study of Kidney Injury, run by BioPorto Diagnostics at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury
- What is being tested?
- NGAL Test
- Type of treatment
- Medical device
- How many people
- 530 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2017to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients diagnosed at high risk for developing AKI.
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brock Katherine
- Recruiting
Colorado Kidney Care
Denver, Colorado, 80218
Melanie Foster-Schwartz
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Kidney Injury
- Being tested
- NGAL Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGAL TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Injury | Not described Receives: Device: NGAL Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 days in ICU or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioPorto Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057457
- Sponsor's protocol ID
- NGAL-001
- Status last verified
- Mar 2017
- First submitted
- 13 Feb 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
- ClinicalTrials.gov ID
- NCT03057457
- Acronym / sponsor ID
- NGAL-001
- Conditions
- Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- BioPorto DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Injury | – | Device: NGAL Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients diagnosed at high risk for developing AKI.
Key inclusion criteria (5 listed)
- • 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.
- o Cardiovascular SOFA score of >= 1(MAP<70 mmHg and/or receiving any vasopressor support
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGAL TestThe 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. | Device | Kidney Injury |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Kidney Injury
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, run by BioPorto Diagnostics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patsy Folio (480-735-9035, patsy.folio@precisionformedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: Up to 7 days in ICU or until discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.