CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 5 enrolled
Drug / intervention
Atorvastatin and anakinradrug
Likely dose
Atorvastatin and anakinra 8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04747847
NCT04747847Early Ph 1Completed

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

University of California, San Diego·interventional·Posted Feb 10, 2021·Updated Feb 25, 2026

In Brief

A Early Phase 1 clinical trial evaluating Atorvastatin and anakinra for Kawasaki Disease. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedFeb 10, 2021
Enrollment StartJun 22, 2019
Primary CompletionAug 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.4 years ago

Interventions

Atorvastatin and anakinradrug

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