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

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ClinicalTrials.gov Identifier: NCT02179853
Recruitment Status : Recruiting
First Posted : July 2, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: Anakinra Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Study Start Date : November 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease
Drug Information available for: Anakinra
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Anakinra
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
Drug: Anakinra
First two doses IV followed by SQ dosing
Other Name: Kineret


Outcome Measures

Primary Outcome Measures :
  1. Safety of a 2 or 6 week course of anakinra [ Time Frame: 2 to 6 weeks ]
    The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.


Secondary Outcome Measures :
  1. Activity of anakinra for 6 weeks [ Time Frame: At baseline, 2 weeks and 6 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179853


Contacts
Contact: Adriana H Tremoulet, MD, MAS 858-246-0012 atremoulet@ucsd.edu

Locations
United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92191
Contact: Adriana H Tremoulet, MD, MAS    858-246-0012    atremoulet@ucsd.edu   
Principal Investigator: Adriana H Tremoulet, MD, MAS         
Sub-Investigator: Jane C Burns, MD         
Sponsors and Collaborators
University of California, San Diego
Boston Children’s Hospital
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Adriana H Tremoulet, MD UCSD
Study Director: Jane C Burns, MD UCSD
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adriana H. Tremoulet, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02179853     History of Changes
Other Study ID Numbers: KD Anakinra
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Adriana H. Tremoulet, University of California, San Diego:
Kawasaki disease
Anakinra
IL-1

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents