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

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.

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rady Children's Hospital San Diego

San Diego, California, 92191, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

First two doses IV followed by SQ dosing

Other names: Kineret

Primary outcomes

Number of Participants With Adverse Events

Time frame: within 6 weeks of treatment

The primary outcome measure was the safety and tolerability of anakinra

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

Boston Children's Hospital
Cedars-Sinai Medical Center

Registry information

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: Jul 2, 2014
Registry last updated: Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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