Summary

Eligibility
for people ages 1-17 (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Adriana H. Tremoulet (ucsd)
Headshot of Adriana H. Tremoulet
Adriana H. Tremoulet

Description

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.

Keywords

Kawasaki Disease, Mucocutaneous Lymph Node Syndrome, Interleukin 1 Receptor Antagonist Protein, Atorvastatin, Atorvastatin and anakinra

Eligibility

You can join if…

Open to people ages 1-17

You CAN'T join if...

  • Taking a CYP3A4 metabolized drug (such as cyclosporine)

Location

  • University of California San Diego
    San Diego California 92093 United States

Lead Scientist at University of California Health

  • Adriana H. Tremoulet (ucsd)
    Dr. Adriana (Adri) Tremoulet is Professor of Pediatrics in the Division of Host-Microbe Systems and Therapeutics in the Department of Pediatrics at UC San Diego, specializing in pediatric infectious diseases and clinical pharmacology.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04747847
Phase
Phase 1 Kawasaki Disease Research Study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated