Clinical trial NCT02179853: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Official title: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kawasaki Disease
Keywords: Kawasaki disease
Anakinra
IL-1
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Cedars-Sinai Medical Center
First posted: 2014-07-02
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: within 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
affiliation: UCSD
name: Adriana H Tremoulet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Jane C Burns, MD
role: STUDY_DIRECTOR
References:
citation: Yang J, Jain S, Capparelli EV, Best BM, Son MB, Baker A, Newburger JW, Franco A, Printz BF, He F, Shimizu C, Hoshino S, Bainto E, Moreno E, Pancheri J, Burns JC, Tremoulet AH. Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/IIa Trial. J Pediatr. 2022 Apr;243:173-180.e8. doi: 10.1016/j.jpeds.2021.12.035. Epub 2021 Dec 23.
citation: Tremoulet AH, Jain S, Kim S, Newburger J, Arditi M, Franco A, Best B, Burns JC. Rationale and study design for a phase I/IIa trial of anakinra in children with Kawasaki disease and early coronary artery abnormalities (the ANAKID trial). Contemp Clin Trials. 2016 May;48:70-5. doi: 10.1016/j.cct.2016.04.002. Epub 2016 Apr 11.