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

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Brief Title

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

Official Title

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

Brief 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 Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Number of participants with treatment-related adverse events


Condition

Kawasaki Disease

Intervention

Atorvastatin and anakinra

Study Arms / Comparison Groups

 Atorvastatin and anakinra
Description:  Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

October 9, 2017

Completion Date

April 2024

Primary Completion Date

November 2023

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)
      

Gender

All

Ages

1 Year - 17 Years

Accepts Healthy Volunteers

No

Contacts

Adriana Tremoulet, MD, 858-246-0012, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04747847

Organization ID

KD Combo

Secondary IDs

R01HL140898

Responsible Party

Principal Investigator

Study Sponsor

University of California, San Diego

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Adriana Tremoulet, MD, Principal Investigator, Professor


Verification Date

March 2022