Last updated on June 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Kawasaki Disease
  • Age: Between 1 - 17 Years
  • Gender: Male or Female

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 (T38oC 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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