10 Participants Needed

Atorvastatin + Anakinra for Kawasaki Disease

AT
Overseen ByAdriana Tremoulet
Age: < 18
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

AT

Adriana Tremoulet, MD

Principal Investigator

Professor

Eligibility Criteria

This trial is for children with Kawasaki Disease who have developed coronary artery abnormalities, specifically with a Z score of 3 or larger in certain arteries. Children cannot participate if they are taking drugs metabolized by the enzyme CYP3A4, like cyclosporine.

Inclusion Criteria

I have Kawasaki disease with significant heart artery enlargement.

Exclusion Criteria

I am currently taking medication that is processed by the liver.

Treatment Details

Interventions

  • Atorvastatin and Anakinra
Trial OverviewThe study tests whether atorvastatin and anakinra can reduce inflammation and prevent damage to the coronary arteries in children with acute Kawasaki Disease who already show early signs of arterial issues.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Atorvastatin and anakinraExperimental Treatment1 Intervention
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+