Trial Outcomes & Findings for Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease (NCT NCT04747847)
NCT ID: NCT04747847
Last Updated: 2026-02-25
Results Overview
The number of participants with adverse events related to study drugs will be assessed and reported
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
5 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-02-25
Participant Flow
Participant milestones
| Measure |
Atorvastatin and Anakinra
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Baseline characteristics by cohort
| Measure |
Atorvastatin and Anakinra
n=5 Participants
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
|
|---|---|
|
Age, Continuous
|
5.1 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Coronary artery abnormalities
|
5 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe number of participants with adverse events related to study drugs will be assessed and reported
Outcome measures
| Measure |
Atorvastatin and Anakinra
n=5 Participants
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
0 Participants
|
Adverse Events
Atorvastatin and Anakinra
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place