Back to resultsPilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Primary Purpose
Kawasaki Disease
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin and anakinra
Sponsored by
About this trial
This is an interventional treatment trial for Kawasaki Disease
Eligibility Criteria
Inclusion Criteria:
- Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA
Exclusion Criteria:
- Taking a CYP3A4 metabolized drug (such as cyclosporine)
Sites / Locations
- University of California San DiegoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atorvastatin and anakinra
Arm Description
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events
The number of participants with adverse events related to study drugs will be assessed and reported
Secondary Outcome Measures
Full Information
NCT ID
NCT04747847
First Posted
February 3, 2021
Last Updated
March 27, 2023
Sponsor
University of California, San Diego
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04747847
Brief Title
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Official Title
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 could lead to complications later in life, including heart attack. Although we 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. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kawasaki Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin and anakinra
Arm Type
Experimental
Arm Description
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Atorvastatin and anakinra
Intervention Description
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day in children with acute KD at least 1 year old with CAA
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
The number of participants with adverse events related to study drugs will be assessed and reported
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA
Exclusion Criteria:
Taking a CYP3A4 metabolized drug (such as cyclosporine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Tremoulet
Phone
858-246-0012
Email
atremoulet@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Tremoulet, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana H. Tremoulet, MD, MAS
Phone
858-246-0012
Email
atremoulet@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Jane C. Burns, MD
Phone
858-246-0155
Email
jcburns@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Jane C Burns, MD
First Name & Middle Initial & Last Name & Degree
Adriana H Tremoulet, MD
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
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