Summary

for people ages 1 month to 17 years (full criteria)
at San Diego, California
study started
estimated completion:
Adriana H Tremoulet

Description

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.

Keywords

Kawasaki Disease Anakinra IL-1 Mucocutaneous Lymph Node Syndrome Interleukin 1 Receptor Antagonist Protein

Eligibility

You can join if…

Open to people ages 1 month to 17 years

  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.

You CAN'T join if...

  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

Location

  • Rady Children's Hospital San Diego accepting new patients
    San Diego California 92191 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02179853
Phase
Phase 1/2
Lead Scientist
Adriana H Tremoulet
Study Type
Interventional
Last Updated
October 24, 2017