NCT02179853

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kawasaki Disease

Interventions

Type	Name	Description
DRUG	Anakinra	First two doses IV followed by SQ dosing

Timeline

• Start date: 2014-11-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2014-07-02
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

1 site across 1 country: United States