Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease|
- Safety of a 2 or 6 week course of anakinra [ Time Frame: 2 to 6 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||October 2020 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02179853
|Contact: Adriana H Tremoulet, MD, MASemail@example.com|
|United States, California|
|Rady Children's Hospital San Diego||Recruiting|
|San Diego, California, United States, 92191|
|Contact: Adriana H Tremoulet, MD, MAS 858-246-0012 firstname.lastname@example.org|
|Principal Investigator: Adriana H Tremoulet, MD, MAS|
|Sub-Investigator: Jane C Burns, MD|
|Principal Investigator:||Adriana H Tremoulet, MD||UCSD|
|Study Director:||Jane C Burns, MD||UCSD|