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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Adriana H. Tremoulet, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02179853
First received: June 28, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Kawasaki Disease
Drug: Anakinra
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Safety of a 6 week course of anakinra [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.


Secondary Outcome Measures:
  • Activity of anakinra for 6 weeks [ Time Frame: At baseline, 2 weeks and 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: October 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
Drug: Anakinra
Other Name: Kineret

  Eligibility

Ages Eligible for Study:   8 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 8 months of age
  2. Meets clinical criteria for KD according to American Heart Association guidelines (Table 1): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery or right coronary artery z-score ≥ 3 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
  3. Patient presents within the first 20 days after fever onset
  4. Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.

Exclusion Criteria:

  1. Use of an IL-1beta antagonist within the 3 months prior to enrollment
  2. Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
  3. Patient taking a tumor necrosis factor α inhibitor (infliximab, etanercept) in the last 2 months
  4. Patient has a history of allergy to anakinra
  5. History of tuberculosis (TB) or TB exposure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179853

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

Locations
United States, California
Rady Children's Hospital San Diego Not yet recruiting
San Diego, California, United States
Principal Investigator: Adriana H Tremoulet, MD, MAS         
Sub-Investigator: Jane C Burns, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Adriana H Tremoulet, MD UCSD
Study Director: Jane C Burns, MD UCSD
  More Information

No publications provided

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
Study First Received: June 28, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014