Acute Kidney InjuryNINJA NGALNCT03527160

Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications

An observational study of Acute Kidney Injury and Nephrotoxicity, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Acute Kidney Injury, Nephrotoxicity
How many people: 134 participants
Where: 2 sitesUnited States
Study dates: 23 Apr 2018to 30 Jun 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All inpatients in non-ICU settings at participating pediatric institutions

Who may be able to join

Receiving 3 or more nephrotoxic medications on the same day OR
Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

Who cannot join

Currently being treated for a urinary tract infection
Presence of an acute kidney injury prior to enrollment

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Children's of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are adequate and reliable compared to urine NGAL measured from the clinical platform.

Conditions: Acute Kidney Injury, Nephrotoxicity
Keywords: AKI, NGAL
Medical subject headings: Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL
AKI, defined as a 50% rise in serum Creatinine over baseline or a 0.3 mg/dL rise within 48 hours, will be first detected by a rise in Urinary NGAL
Measured: 9 Days

Secondary outcomes (1)

Point of Care NGAL Reliability Compared to Clinical Urinary NGAL
A POC urinary NGAL will be determined from a colorimetric assay that determines risk of AKI, which will later be compared to NGAL values from the clinical assay
Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201830 Jun 2019

First posted17 May 2018
Study start23 Apr 2018
Primary completion31 May 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
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: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03527160
Sponsor's protocol ID: CIN001 - NINJA NGAL
Acronym: NINJA NGAL
Status last verified: Sep 2021
First submitted: 4 May 2018
Last updated: 5 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications
ClinicalTrials.gov ID: NCT03527160
Acronym / sponsor ID: NINJA NGAL / CIN001 - NINJA NGAL
Conditions: Acute Kidney Injury, Nephrotoxicity
Keywords: AKI, NGAL
Study type: Observational
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: BioPorto Diagnostics
Study start: 23 Apr 2018 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 17 May 2018 (actual)
Results: Posted 18 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All inpatients in non-ICU settings at participating pediatric institutions

Key inclusion criteria (2 listed)

Receiving 3 or more nephrotoxic medications on the same day OR
Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

Key exclusion criteria (2 listed)

Currently being treated for a urinary tract infection
Presence of an acute kidney injury prior to enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL
Time frame: 9 Days
AKI, defined as a 50% rise in serum Creatinine over baseline or a 0.3 mg/dL rise within 48 hours, will be first detected by a rise in Urinary NGAL

1 secondary outcome

Point of Care NGAL Reliability Compared to Clinical Urinary NGAL
Time frame: 7 Days

Results and safety

Results posted to the registry on 18 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NINJA	134	113

Primary outcome: Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL

Time frame: 9 Days. Count of participants. Unit: Participants

Measure	Any AKI n = 27	No AKI n = 86
NGAL >= 150 ng/mL	3	6
NGAL < 150 ng/mL	24	80

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Maximum of 9 days of exposure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NINJA	0 of 113 (0%)	0 of 113 (0%)	0 of 113

Limitations and caveats (from the sponsor): This study had a relatively small sample size with only 27 participants developing AKI. Additionally, this study was performed in non-critically ill children and the findings may not be applicable to a broader population of hospitalized children and adults.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Kidney Injury

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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Not yet recruiting
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Recruiting
Acute Kidney Injury and Ultra-endurance Running
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Recruiting
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Not yet recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Acute Kidney Injury and Nephrotoxicity, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Oct 2021. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL (time frame: 9 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03527160.

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 5 Oct 2021.