Overview

Non Inferiority KawasakI Trial With Anakinra

Status:
NOT_YET_RECRUITING
Trial end date:
2027-04-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, randomized, controlled, interventional trial followed by a long-term observational extension period in patients with Kawasaki Disease (KD) to be treated eitherwith endovenous Immunoglobulins (IVIG-standard treatment) versus anakinra Aim of the study: to demonstrate that anakinra is non-inferior to IVIG in KD, in terms of fever control in the acute phase and development of coronary artery dilation/aneurisms (CAA) within one year from the onset.
Phase:
PHASE4
Details
Lead Sponsor:
Meyer Children's Hospital IRCCS
Collaborators:
Asst Degli Spedali Civili Di Brescia
IRCCS Burlo Garofolo
Treatments:
Immunoglobulins, Intravenous
Interleukin 1 Receptor Antagonist Protein