Atorvastatin + Anakinra for Kawasaki Disease

Overseen By Adriana Tremoulet

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Diego

Must not be taking: CYP3A4 drugs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Adriana Tremoulet, MD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combination therapy with atorvastatin and anakinra for coronary artery abnormalities in Kawasaki disease

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atorvastatin and Anakinra

Trial Overview The 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.

How Is the Trial Designed?

Group I: Atorvastatin and anakinra Experimental Treatment 1 Intervention

Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

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+