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Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Primary Purpose

Kawasaki Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Atorvastatin

About this trial

This is an interventional treatment trial for Kawasaki Disease focused on measuring Kawasaki disease

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age ≥ 2 years to 17 years old
Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
Patient presents within the first 20 days after fever onset
Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
Males engaging in sexual activity that could lead to pregnancy must use a condom.

Exclusion Criteria:

Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
Patient has a history of allergy to atorvastatin or its derivatives

Sites / Locations

University of California San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvasatin

Arm Description

Atorvastatin dose titration to maximum tolerated dose

Outcomes

Primary Outcome Measures

Number of Participants With SAE

Number of participants who experienced an SAE within the 6 week study period

Secondary Outcome Measures

Full Information

NCT ID

NCT01431105

First Posted

September 6, 2011

Last Updated

May 4, 2020

Sponsor

University of California, San Diego

Collaborators

Children's Hospital Colorado, University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT01431105

Brief Title

Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Official Title

Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Children's Hospital Colorado, University of Colorado, Denver

4. Oversight

Data Monitoring Committee

Yes

5. 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 investigators 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. Inflammation and damage to the arterial wall is central to these coronary artery abnormalities. 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. Therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from KD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kawasaki Disease

Keywords

Kawasaki disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvasatin

Arm Type

Experimental

Arm Description

Atorvastatin dose titration to maximum tolerated dose

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)

Primary Outcome Measure Information:

Title

Number of Participants With SAE

Description

Number of participants who experienced an SAE within the 6 week study period

Time Frame

At 6 weeks after initiation of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age ≥ 2 years to 17 years old Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries Patient presents within the first 20 days after fever onset Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate. Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study Males engaging in sexual activity that could lead to pregnancy must use a condom. Exclusion Criteria: Use of a statin, fibrate, or niacin within the 3 months prior to enrollment Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days Patient has a history of allergy to atorvastatin or its derivatives

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane C Burns, MD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27923814

Citation

He M, Chen Z, Martin M, Zhang J, Sangwung P, Woo B, Tremoulet AH, Shimizu C, Jain MK, Burns JC, Shyy JY. miR-483 Targeting of CTGF Suppresses Endothelial-to-Mesenchymal Transition: Therapeutic Implications in Kawasaki Disease. Circ Res. 2017 Jan 20;120(2):354-365. doi: 10.1161/CIRCRESAHA.116.310233. Epub 2016 Dec 6.

Results Reference

derived

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Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

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