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

Phase 1

Completed

• Conditions: Kawasaki Disease
• Interventions: Drug: Anakinra

• Registration Number: NCT02179853
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-28
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-02
• Study Start: 2014-11
• Primary Completion: 2022-10
• Study Completion: 2022-12
• Results First Submitted: 2023-08-06
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Results First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anakinra	Anakinra	This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	within 6 weeks of treatment	The primary outcome measure was the safety and tolerability of anakinra

Trial Locations

Locations (1)

Rady Children's Hospital San Diego; 🇺🇸 San Diego, California, United States