Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
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|ClinicalTrials.gov Identifier: NCT02179853|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2014
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Kawasaki Disease||Drug: Anakinra||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||December 2021|
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
First two doses IV followed by SQ dosing
Other Name: Kineret
- Safety of a 2 or 6 week course of anakinra [ Time Frame: 2 to 6 weeks ]The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.
- Activity of anakinra for 6 weeks [ Time Frame: At baseline, 2 weeks and 6 weeks ]Blood will be tested pre-drug administration, at 2 weeks and at 6 weeks for markers of inflammation and enumeration of regulatory T-cells. Echocardiographic assessment of coronary arteries at these time points will be compared to historical controls matched for age, sex and coronary artery status on initial echo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179853
|United States, California|
|Rady Children's Hospital San Diego|
|San Diego, California, United States, 92191|
|Principal Investigator:||Adriana H Tremoulet, MD||UCSD|
|Study Director:||Jane C Burns, MD||UCSD|