Trial Outcomes & Findings for Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease (NCT NCT02179853)
NCT ID: NCT02179853
Last Updated: 2024-03-04
Results Overview
The primary outcome measure was the safety and tolerability of anakinra
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
within 6 weeks of treatment
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
Dose Level 1 (Anakinra 2-4 mg/kg/Day)
Participants were administered 2-4 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 2 (Anakinra 5-7 mg/kg/Day)
Participants were administered 5-7 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 3 (Anakinra 8-11 mg/kg/Day)
Participants were administered 8-11 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
15
|
|
Overall Study
COMPLETED
|
4
|
3
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Baseline characteristics by cohort
| Measure |
Dose Level 1 (Anakinra 2-4 mg/kg/Day)
n=4 Participants
Participants were administered 2-4 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 2 (Anakinra 5-7 mg/kg/Day)
n=3 Participants
Participants were administered 5-7 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 3 (Anakinra 8-11 mg/kg/Day)
n=15 Participants
Participants were administered 8-11 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
1.5 years
n=99 Participants
|
0.8 years
n=107 Participants
|
1.2 years
n=206 Participants
|
1.1 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
15 participants
n=206 Participants
|
22 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: within 6 weeks of treatmentThe primary outcome measure was the safety and tolerability of anakinra
Outcome measures
| Measure |
Dose Level 1 (Anakinra 2-4 mg/kg/Day)
n=4 Participants
Participants were administered 2-4 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 1 (Anakinra 5-7 mg/kg/Day)
n=3 Participants
Participants were administered 5-7 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 3 (Anakinra 8-11 mg/kg/Day)
n=15 Participants
Participants were administered 8-11 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
2 participants
|
3 participants
|
13 participants
|
Adverse Events
Dose Level 1 (Anakinra 2-4 mg/kg/Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 2 (Anakinra 5-7 mg/kg/Day)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3 (Anakinra 8-11 mg/kg/Day)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Level 1 (Anakinra 2-4 mg/kg/Day)
n=4 participants at risk
Participants were administered 2-4 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 2 (Anakinra 5-7 mg/kg/Day)
n=3 participants at risk
Participants were administered 5-7 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
Dose Level 3 (Anakinra 8-11 mg/kg/Day)
n=15 participants at risk
Participants were administered 8-11 mg/kg/day of Anakinra intravenously every 12 hours for the first 24 hours and subsequently administered subcutaneously every 24 hours.
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery aneurysm
|
0.00%
0/4 • 6 weeks
The definition does not differ
|
33.3%
1/3 • Number of events 1 • 6 weeks
The definition does not differ
|
13.3%
2/15 • Number of events 2 • 6 weeks
The definition does not differ
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Number of events 2 • 6 weeks
The definition does not differ
|
0.00%
0/3 • 6 weeks
The definition does not differ
|
60.0%
9/15 • Number of events 9 • 6 weeks
The definition does not differ
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/4 • 6 weeks
The definition does not differ
|
66.7%
2/3 • Number of events 2 • 6 weeks
The definition does not differ
|
13.3%
2/15 • Number of events 2 • 6 weeks
The definition does not differ
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place