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

NCT02179853 | Completed Phase 1 Results DMC

• 1 other identifier: KD Anakinra
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Kawasaki Disease

Keywords

Kawasaki disease; Anakinra; IL-1

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  The primary outcome measure was the safety and tolerability of anakinra

  within 6 weeks of treatment

Study Arms (1)

Anakinra

EXPERIMENTAL

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

Drug: Anakinra

Interventions

Anakinra DRUG

First two doses IV followed by SQ dosing

Also known as: Kineret

Anakinra

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Boston Children's Hospital: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92191, United States

Location

Related Publications (2)

• 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.

  PMID: 34953816 BACKGROUND

• 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.

  PMID: 27080929 DERIVED

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Adriana Tremoulet
• Organization: UCSD

atremoulet@health.ucsd.edu

858-246-0012

Study Officials

• Adriana H Tremoulet, MD

  UCSD

  PRINCIPAL INVESTIGATOR

• Jane C Burns, MD

  UCSD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2014
• First Posted: July 2, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-03

Locations

US (1)