Clinical Trial: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Brief Summary: Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old with coronary artery abnormalities from KD.

Detailed Summary:
Sponsor: University of California, San Diego

Current Primary Outcome: 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.


Original Primary Outcome: Safety of a 6 week course of anakinra [ Time Frame: 6 weeks ]

The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.


Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: June 28, 2014
Date Started: November 2014
Date Completion: December 2020
Last Updated: May 11, 2016
Last Verified: May 2016