Trial Outcomes & Findings for Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications (NCT NCT03527160)

NCT ID: NCT03527160

Last Updated: 2021-10-05

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 134 participants
• Primary outcome timeframe: 9 Days
• Results posted on: 2021-10-05

Participant Flow

Participant milestones

Measure	NINJA Inpatients exposed to nephrotoxic medications
Overall Study STARTED	134
Overall Study COMPLETED	113
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	NINJA Inpatients exposed to nephrotoxic medications
Overall Study No urine collected	13
Overall Study No clinical serum creatinine collected	6
Overall Study Did not meet inclusion	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Any AKI n=27 Participants Patients developed AKI during study	No AKI n=86 Participants Patients did not develop AKI over the course of the study	Total n=113 Participants Total of all reporting groups
Age, Continuous	16.2 years n=5 Participants	12.0 years n=7 Participants	13.2 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	45 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	41 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	83 Participants n=7 Participants	110 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	66 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Weight	47.1 kilograms n=5 Participants	39.9 kilograms n=7 Participants	42.3 kilograms n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Any AKI n=27 Participants Patients developed Nephrotoxic Medication Associated AKI during study	No AKI n=86 Participants Patients did not develop Nephrotoxic Medication Associated AKI over the course of the study
Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL NGAL >= 150 ng/mL	3 Participants	6 Participants
Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL NGAL < 150 ng/mL	24 Participants	80 Participants

SECONDARY outcome

Timeframe: 7 Days

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

Outcome measures

Measure	Any AKI n=51 Participants Patients developed Nephrotoxic Medication Associated AKI during study	No AKI n=62 Participants Patients did not develop Nephrotoxic Medication Associated AKI over the course of the study
Point of Care NGAL Reliability Compared to Clinical Urinary NGAL AKI	10 Participants	16 Participants
Point of Care NGAL Reliability Compared to Clinical Urinary NGAL No AKI	41 Participants	46 Participants

Adverse Events

NINJA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stuart Goldstein

Cincinnati Children's Hospital Medical Center

Phone: 513-636-2209

Email: stuart.goldstein@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place