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

NCT ID: NCT04747847

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2025-04-30

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.

Conditions

Kawasaki Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin and anakinra

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

Group Type: EXPERIMENTAL

Atorvastatin and anakinra

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Adriana H. Tremoulet

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana Tremoulet, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

University of California San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

R01HL140898

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KD Combo

Identifier Type: -

Identifier Source: org_study_id