CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Anakinradrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02179853
NCT02179853Phase 2Completed

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

University of California, San Diego·interventional·Posted Jul 2, 2014·Updated Mar 4, 2024

In Brief

A Phase 2 clinical trial evaluating Anakinra for Kawasaki Disease. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2, 2014
Enrollment StartNov 1, 2014
Primary CompletionOct 1, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 12 years ago

Interventions

Anakinradrug

First two doses IV followed by SQ dosing