- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02179853
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
March 1, 2024 updated by: Adriana H. Tremoulet, University of California, San Diego
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92191
- Rady Children's Hospital San Diego
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Anakinra
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
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First two doses IV followed by SQ dosing
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: within 6 weeks of treatment
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The primary outcome measure was the safety and tolerability of anakinra
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within 6 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity of anakinra for 6 weeks
Time Frame: At baseline, 2 weeks and 6 weeks
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Blood will be tested pre-drug administration, at 2 weeks and at 6 weeks for markers of inflammation and enumeration of regulatory T-cells.
Echocardiographic assessment of coronary arteries at these time points will be compared to historical controls matched for age, sex and coronary artery status on initial echo.
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At baseline, 2 weeks and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adriana H Tremoulet, MD, UCSD
- Study Director: Jane C Burns, MD, UCSD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
June 28, 2014
First Submitted That Met QC Criteria
June 30, 2014
First Posted (Estimated)
July 2, 2014
Study Record Updates
Last Update Posted (Actual)
March 4, 2024
Last Update Submitted That Met QC Criteria
March 1, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KD Anakinra
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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