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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of California, San Diego
Boston Children’s Hospital
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Adriana H. Tremoulet, University of California, San Diego Identifier:
First received: June 28, 2014
Last updated: May 11, 2016
Last verified: May 2016
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 Intervention Phase
Kawasaki Disease
Drug: Anakinra
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Safety of a 2 or 6 week course of anakinra [ Time Frame: 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:
  • Activity of anakinra for 6 weeks [ Time Frame: 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.

Estimated Enrollment: 10
Study Start Date: November 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Kineret


Ages Eligible for Study:   8 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Infant or child aged 8 months 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02179853

Contact: Adriana H Tremoulet, MD, MAS 858-246-0012

United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92191
Contact: Adriana H Tremoulet, MD, MAS    858-246-0012   
Principal Investigator: Adriana H Tremoulet, MD, MAS         
Sub-Investigator: Jane C Burns, MD         
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Adriana H. Tremoulet, Associate Professor, University of California, San Diego Identifier: NCT02179853     History of Changes
Other Study ID Numbers: KD Anakinra
Study First Received: June 28, 2014
Last Updated: May 11, 2016

Keywords provided by University of California, San Diego:
Kawasaki disease

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents processed this record on May 22, 2017