Phase 2 N=22 Treatment

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

Kawasaki Disease

Bottom Line

View on ClinicalTrials.gov: NCT02179853 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Number of Participants With Adverse Events — 2; 3; 13 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Anakinra (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	2; 3; 13	—

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.

Eligibility Criteria

Inclusion Criteria

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
Patient presents within the first 20 days after fever onset
Parent or legal guardian able and willing to provide informed consent; adolescent or child assent as appropriate
Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
Males engaging in sexual activity that could lead to pregnancy willing to use a condom.

Exclusion Criteria

Use of an IL-1 antagonist within the 3 months prior to enrollment
History of chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
History of hypersensitivity to anakinra
History of tuberculosis (TB) or TB exposure

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02179853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.