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

Early Phase 1

Active, not recruiting

• Conditions: Kawasaki Disease
• Interventions: Drug: Atorvastatin and anakinra

• Registration Number: NCT04747847
• Lead Sponsor: University of California, San Diego

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-09
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-06
• Study First Posted: 2021-02-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-11
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA

Exclusion Criteria

• Taking a CYP3A4 metabolized drug (such as cyclosporine)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvastatin and anakinra	Atorvastatin and anakinra	Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	6 weeks	The number of participants with adverse events related to study drugs will be assessed and reported

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 San Diego, California, United States