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Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Primary Purpose

Kawasaki Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Anakinra

About this trial

This is an interventional treatment trial for Kawasaki Disease focused on measuring Kawasaki disease, Anakinra, IL-1

Eligibility Criteria

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

Inclusion Criteria:

Infant or child aged 1 month to 17 years, who 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 (LAD)/right coronary artery (RCA) Z score ≥ 3.0 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary artery segments
Patient presents within the first 20 days after fever onset
Parent or legal guardian able and willing to provide informed consent; adolescent or child assent as 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 willing to use a condom.

Exclusion Criteria:

Use of an IL-1 antagonist within the 3 months prior to enrollment
History of chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
History of hypersensitivity to anakinra
History of tuberculosis (TB) or TB exposure

Sites / Locations

Rady Children's Hospital San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anakinra

Arm Description

This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).

Outcomes

Primary Outcome Measures

Safety of a 2 or 6 week course of anakinra

The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.

Secondary Outcome Measures

Activity of anakinra for 6 weeks

Blood will be tested pre-drug administration, at 2 weeks and at 6 weeks for markers of inflammation and enumeration of regulatory T-cells. Echocardiographic assessment of coronary arteries at these time points will be compared to historical controls matched for age, sex and coronary artery status on initial echo.

Full Information

NCT ID

NCT02179853

First Posted

June 28, 2014

Last Updated

March 27, 2023

Sponsor

University of California, San Diego

Collaborators

Boston Children's Hospital, Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02179853

Brief Title

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Official Title

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2022 (Actual)

Study Completion Date

December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Boston Children's Hospital, Cedars-Sinai Medical Center

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 may lead to complications later in life, including heart attack. Although the 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. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old 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, Anakinra, IL-1

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

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anakinra

Arm Type

Experimental

Arm Description

This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).

Intervention Type

Drug

Intervention Name(s)

Anakinra

Other Intervention Name(s)

Kineret

Intervention Description

First two doses IV followed by SQ dosing

Primary Outcome Measure Information:

Title

Safety of a 2 or 6 week course of anakinra

Description

The safety of anakinra will be assessed by monitoring for clinical and laboratory signs of infection and injection site reactions.

Time Frame

2 to 6 weeks

Secondary Outcome Measure Information:

Title

Activity of anakinra for 6 weeks

Description

Time Frame

At baseline, 2 weeks and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infant or child aged 1 month to 17 years, who 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 (LAD)/right coronary artery (RCA) Z score ≥ 3.0 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary artery segments Patient presents within the first 20 days after fever onset Parent or legal guardian able and willing to provide informed consent; adolescent or child assent as 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 willing to use a condom. Exclusion Criteria: Use of an IL-1 antagonist within the 3 months prior to enrollment History of chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder History of hypersensitivity to anakinra History of tuberculosis (TB) or TB exposure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adriana H Tremoulet, MD

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jane C Burns, MD

Organizational Affiliation

UCSD

Official's Role

Study Director

Facility Information:

Facility Name

Rady Children's Hospital San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92191

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34953816

Citation

Yang J, Jain S, Capparelli EV, Best BM, Son MB, Baker A, Newburger JW, Franco A, Printz BF, He F, Shimizu C, Hoshino S, Bainto E, Moreno E, Pancheri J, Burns JC, Tremoulet AH. Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/IIa Trial. J Pediatr. 2022 Apr;243:173-180.e8. doi: 10.1016/j.jpeds.2021.12.035. Epub 2021 Dec 23.

Results Reference

background

PubMed Identifier

27080929

Citation

Tremoulet AH, Jain S, Kim S, Newburger J, Arditi M, Franco A, Best B, Burns JC. Rationale and study design for a phase I/IIa trial of anakinra in children with Kawasaki disease and early coronary artery abnormalities (the ANAKID trial). Contemp Clin Trials. 2016 May;48:70-5. doi: 10.1016/j.cct.2016.04.002. Epub 2016 Apr 11.

Results Reference

derived

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Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

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