Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
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| ClinicalTrials.gov Identifier: NCT04747847 |
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Recruitment Status :
Recruiting
First Posted : February 10, 2021
Last Update Posted : March 3, 2022
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Sponsor:
University of California, San Diego
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Adriana H. Tremoulet, University of California, San Diego
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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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | October 9, 2017 |
| Estimated Primary Completion Date : | November 2023 |
| Estimated Study Completion Date : | April 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Kawasaki disease
MedlinePlus related topics:
Kawasaki Disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atorvastatin and anakinra
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
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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 |
Primary Outcome Measures :
- Number of participants with treatment-related adverse events [ Time Frame: 6 weeks ]The number of participants with adverse events related to study drugs will be assessed and reported
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| Ages Eligible for Study: | 1 Year to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747847
Contacts
| Contact: Adriana Tremoulet | 858-246-0012 | atremoulet@health.ucsd.edu |
Locations
| United States, California | |
| University of California San Diego | Recruiting |
| San Diego, California, United States, 92093 | |
| Contact: Adriana H. Tremoulet, MD, MAS 858-246-0012 atremoulet@ucsd.edu | |
| Contact: Jane C. Burns, MD 858-246-0155 jcburns@ucsd.edu | |
| Principal Investigator: Jane C Burns, MD | |
| Sub-Investigator: Adriana H Tremoulet, MD | |
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Adriana Tremoulet, MD | Professor |
| Responsible Party: | Adriana H. Tremoulet, Professor, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT04747847 |
| Other Study ID Numbers: |
KD Combo R01HL140898 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 10, 2021 Key Record Dates |
| Last Update Posted: | March 3, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome Vasculitis Vascular Diseases Cardiovascular Diseases Lymphatic Diseases Skin Diseases, Vascular Skin Diseases Interleukin 1 Receptor Antagonist Protein Atorvastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Antirheumatic Agents |