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

University of California San Diego

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Kawasaki Disease

Treatments: Drug: Atorvastatin and anakinra

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04747847

R01HL140898 (U.S. NIH Grant/Contract)

KD Combo

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Atorvastatin and anakinra

Experimental group

Description:

Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

Treatment:

Drug: Atorvastatin and anakinra