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

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

Sponsors

Lead Sponsor: University of California, San Diego

Collaborator: Boston Children's Hospital
Cedars-Sinai Medical Center

Source 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.

Overall Status Recruiting
Start Date November 2014
Completion Date December 2020
Primary Completion Date October 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety of a 2 or 6 week course of anakinra 2 to 6 weeks
Secondary Outcome
Measure Time Frame
Activity of anakinra for 6 weeks At baseline, 2 weeks and 6 weeks
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Anakinra

Description: First two doses IV followed by SQ dosing

Arm Group Label: Anakinra

Other Name: Kineret

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

Gender: All

Minimum Age: 1 Month

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Adriana H Tremoulet, MD, MAS

Phone: 858-246-0012

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Rady Children's Hospital San Diego Adriana H Tremoulet, MD, MAS 858-246-0012 [email protected] Adriana H Tremoulet, MD, MAS Principal Investigator Jane C Burns, MD Sub-Investigator
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of California, San Diego

Investigator Full Name: Adriana H. Tremoulet

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Anakinra

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov