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Statins and Interleukin-1 (IL-1) Inhibitor

Atorvastatin + Anakinra for Kawasaki Disease

Phase < 1
Waitlist Available
Led By Adriana Tremoulet, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA
Be younger than 18 years old
Must not have
Taking a CYP3A4 metabolized drug (such as cyclosporine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of combination therapy with atorvastatin and anakinra in children with acute Kawasaki Disease and early coronary artery abnormalities.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Atorvastatin may cause muscle pain, digestive problems, and liver function changes. Anakinra might lead to injection site reactions, increased risk of infections, headaches, and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Kawasaki disease with significant heart artery enlargement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking medication that is processed by the liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,046 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,934 Previous Clinical Trials
47,792,266 Total Patients Enrolled
Adriana Tremoulet, MDPrincipal InvestigatorProfessor

Media Library

Atorvastatin and Anakinra (Statins and Interleukin-1 (IL-1) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04747847 — Phase < 1
Kawasaki Disease Research Study Groups: Atorvastatin and anakinra
Kawasaki Disease Clinical Trial 2023: Atorvastatin and Anakinra Highlights & Side Effects. Trial Name: NCT04747847 — Phase < 1
Atorvastatin and Anakinra (Statins and Interleukin-1 (IL-1) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747847 — Phase < 1
~1 spots leftby Nov 2025
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