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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 : June 5, 2020
Sponsor:
Collaborators:
Boston Children’s Hospital
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Adriana H. Tremoulet, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE June 28, 2014
First Posted Date  ICMJE July 2, 2014
Last Update Posted Date June 5, 2020
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
Safety of a 6 week course of anakinra [ Time Frame: 6 weeks ]
The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Official Title  ICMJE Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kawasaki Disease
Intervention  ICMJE Drug: Anakinra
First two doses IV followed by SQ dosing
Other Name: Kineret
Study Arms  ICMJE Experimental: Anakinra
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
Intervention: Drug: Anakinra
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adriana H Tremoulet, MD, MAS 858-246-0012 atremoulet@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02179853
Other Study ID Numbers  ICMJE KD Anakinra
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adriana H. Tremoulet, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE
  • Boston Children’s Hospital
  • Cedars-Sinai Medical Center
Investigators  ICMJE
Principal Investigator: Adriana H Tremoulet, MD UCSD
Study Director: Jane C Burns, MD UCSD
PRS Account University of California, San Diego
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP