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Early Phase 1 N=5 Treatment

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

Kawasaki Disease

Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events — 0 Participants

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
Atorvastatin and anakinra (Drug)
Age
Pediatric · 1+ yrs
Sex
All
Sponsor
University of California, San Diego
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Treatment-related Adverse Events

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.

Eligibility Criteria

Inclusion Criteria

  • Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA

Exclusion Criteria

  • Taking a CYP3A4 metabolized drug (such as cyclosporine)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04747847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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