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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL140898 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin and anakinra | Experimental | Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin and anakinra | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | The number of participants with adverse events related to study drugs will be assessed and reported | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana Tremoulet, MD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92093 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin and Anakinra | Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin and Anakinra | Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events | The number of participants with adverse events related to study drugs will be assessed and reported | Posted | Count of Participants | Participants | 6 weeks |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin and Anakinra | Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adriana Tremoulet | University of California San Diego | 858-246-0012 | atremoulet@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2022 | Oct 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Coronary artery abnormalities | Count of Participants | Participants |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |