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 ]
Original Primary Outcome: Safety of a 6 week course of anakinra [ Time Frame: 6 weeks ]
Current Secondary Outcome: Activity of anakinra for 6 weeks [ Time Frame: At baseline, 2 weeks and 6 weeks ]
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