NCT04747847

Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 1 Year – 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 could lead to complications later in life, including heart attack. Although we 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. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.

Conditions

• Kawasaki Disease

Interventions

Type	Name	Description
DRUG	Atorvastatin and anakinra	Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day in children with acute KD at least 1 year old with CAA

Timeline

• Start date: 2019-06-22
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2021-02-10
• Last updated: 2026-02-25
• Results posted: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study