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

Kawasaki Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179853
• Other study ID #: KD Anakinra
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2014
• Est. completion date: December 2022

Study information

• Verified date: March 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• Anakinra
First two doses IV followed by SQ dosing

Locations

Country	Name	City	State
United States	Rady Children's Hospital San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Boston Children's Hospital, Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	The primary outcome measure was the safety and tolerability of anakinra	within 6 weeks of treatment