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

NCT04747847 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: KD ComboR01HL140898
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events

  The number of participants with adverse events related to study drugs will be assessed and reported

  6 weeks

Study Arms (1)

Atorvastatin and anakinra

EXPERIMENTAL

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

Drug: Atorvastatin and anakinra

Interventions

Atorvastatin and anakinra 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

Atorvastatin and anakinra

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Taking a CYP3A4 metabolized drug (such as cyclosporine)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Atorvastatin; Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Adriana Tremoulet
• Organization: University of California San Diego

atremoulet@health.ucsd.edu

858-246-0012

Study Officials

• Adriana Tremoulet, MD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 10, 2021
• Study Start: June 22, 2019
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Locations

US (1)