Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

University of California, San Diego (Other)
Overall Status
Active, not recruiting ID
Boston Children's Hospital (Other), Cedars-Sinai Medical Center (Other)

Study Details

Study Description

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 may lead to complications later in life, including heart attack. Although the investigators 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. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old with coronary artery abnormalities from KD.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Anticipated Enrollment :
10 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anakinra

This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).

Drug: Anakinra
First two doses IV followed by SQ dosing
Other Names:
  • Kineret
  • Outcome Measures

    Primary Outcome Measures

    1. Safety of a 2 or 6 week course of anakinra [2 to 6 weeks]

      The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.

    Secondary Outcome Measures

    1. Activity of anakinra for 6 weeks [At baseline, 2 weeks and 6 weeks]

      Blood will be tested pre-drug administration, at 2 weeks and at 6 weeks for markers of inflammation and enumeration of regulatory T-cells. Echocardiographic assessment of coronary arteries at these time points will be compared to historical controls matched for age, sex and coronary artery status on initial echo.

    Eligibility Criteria


    Ages Eligible for Study:
    1 Month to 17 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    1. Infant or child aged 1 month to 17 years, who meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending (LAD)/right coronary artery (RCA) Z score ≥ 3.0 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary artery segments

    2. Patient presents within the first 20 days after fever onset

    3. Parent or legal guardian able and willing to provide informed consent; adolescent or child assent as appropriate

    4. Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study

    5. Males engaging in sexual activity that could lead to pregnancy willing to use a condom.

    Exclusion Criteria:
    1. Use of an IL-1 antagonist within the 3 months prior to enrollment

    2. History of chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder

    3. History of hypersensitivity to anakinra

    4. History of tuberculosis (TB) or TB exposure

    Contacts and Locations


    Site City State Country Postal Code
    1 Rady Children's Hospital San Diego San Diego California United States 92191

    Sponsors and Collaborators

    • University of California, San Diego
    • Boston Children's Hospital
    • Cedars-Sinai Medical Center


    • Principal Investigator: Adriana H Tremoulet, MD, UCSD
    • Study Director: Jane C Burns, MD, UCSD

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Adriana H. Tremoulet, Associate Professor, University of California, San Diego Identifier:
    Other Study ID Numbers:
    • KD Anakinra
    First Posted:
    Jul 2, 2014
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Adriana H. Tremoulet, Associate Professor, University of California, San Diego
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2022