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Interleukin-1 (IL-1) Receptor Antagonist

Anakinra for Kawasaki Disease

Phase 1 & 2
Waitlist Available
Led By Adriana H Tremoulet, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 2 weeks and 6 weeks
Awards & highlights

Study Summary

This trial will test whether or not anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, is safe and effective in preventing the development of coronary artery damage in children with KD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 2 weeks and 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 2 weeks and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events
Secondary outcome measures
Activity of anakinra for 6 weeks

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

Trial Design

1Treatment groups
Experimental Treatment
Group I: AnakinraExperimental Treatment1 Intervention
This is a dose escalation study (4 mg/kg, 6 mg/kg and 8 mg/kg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~2260

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,520,902 Total Patients Enrolled
Boston Children's HospitalOTHER
761 Previous Clinical Trials
5,579,708 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
500 Previous Clinical Trials
164,841 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Contemporary Clinical TrialsJournal
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)
Tremoulet, Adriana H., Sonia Jain, Susan Kim, Jane Newburger, Moshe Arditi, Alessandra Franco, Brookie Best, and Jane C. Burns. 2016. “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)”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2016.04.002.
The Journal of PediatricsJournal
Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/iia Trial
Yang, Jincheng, Sonia Jain, Edmund V. Capparelli, Brookie M. Best, Mary Beth Son, Annette Baker, Jane W. Newburger, et al.. 2022. “Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/iia Trial”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2021.12.035.
clinicaltrials.govStudy
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Adriana H. Tremoulet 2014. "Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02179853.
~2 spots leftby Apr 2025
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