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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04747847
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 77.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kawasaki Disease	Drug: Atorvastatin and anakinra	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
• Actual Study Start Date: Oct 9, 2017
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atorvastatin and anakinra Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day	Drug: Atorvastatin and anakinra; 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

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-related adverse events [6 weeks]

   The number of participants with adverse events related to study drugs will be assessed and reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego	San Diego	California	United States	92093

Sponsors and Collaborators

• University of California, San Diego
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Adriana Tremoulet, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adriana H. Tremoulet, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT04747847
• Other Study ID Numbers: KD Combo; R01HL140898
• First Posted: Feb 10, 2021
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mucocutaneous Lymph Node Syndrome; Interleukin 1 Receptor Antagonist Protein; Atorvastatin

Study Results

No Results Posted as of Mar 3, 2022