Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747847
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Adriana H. Tremoulet, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: Atorvastatin and anakinra Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: Atorvastatin and anakinra
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
Drug: Atorvastatin and anakinra
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 Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 6 weeks ]
    The number of participants with adverse events related to study drugs will be assessed and reported



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT04747847


Contacts
Layout table for location contacts
Contact: Adriana Tremoulet 858-246-0012 atremoulet@health.ucsd.edu

Locations
Layout table for location information
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Adriana H. Tremoulet, MD, MAS    858-246-0012    atremoulet@ucsd.edu   
Contact: Jane C. Burns, MD    858-246-0155    jcburns@ucsd.edu   
Principal Investigator: Jane C Burns, MD         
Sub-Investigator: Adriana H Tremoulet, MD         
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Adriana Tremoulet, MD Professor
Layout table for additonal information
Responsible Party: Adriana H. Tremoulet, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04747847    
Other Study ID Numbers: KD Combo
R01HL140898 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Interleukin 1 Receptor Antagonist Protein
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antirheumatic Agents