Trial Outcomes & Findings for Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy (NCT NCT02786810)

Last Updated: 2018-05-11

Results Overview

The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

1 hour

Results posted on

2018-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Contrast All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast n=10 Participants All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound
Age, Categorical <=18 years	7 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Sex: Female, Male Female	7 Participants n=39 Participants
Sex: Female, Male Male	3 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants
Race (NIH/OMB) White	9 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: In addition to the 7 patients analyzed, 3 participants were excluded from this analysis because they did not have previous scars to analyze.

Outcome measures

Outcome measures
Measure	Contrast n=7 Participants All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound
Visualization of Renal Scars Compared to Previous Imaging	100 Percentage of previous scars visualized

SECONDARY outcome

Timeframe: 1 week

The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study.

Outcome measures

Outcome measures
Measure	Contrast n=10 Participants All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound
Number of Participants With Adverse Events Related to the Study Drug.	1 participants

Adverse Events

Contrast

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Contrast n=10 participants at risk All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound
General disorders Mild Headache	10.0% 1/10 • Number of events 1 • 1 week

Additional Information

Dr. David Hains

University of Tennessee Health Science Center

Phone: 9012874876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place