Non Inferiority KawasakI Trial With Anakinra

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2027

Conditions
Kawasaki DiseaseAnakinra
Interventions
DRUG

Anakinra

"Patients who fulfill the eligibility criteria a will be randomized 1:1 to receive either~1. IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR~2. Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment)~Patients showing fever, between 36 hours and 72 hours from the end of first line treatment will be considered failures. Failures from the investigational treatment arm will receive a dose of IVIG and they will drop from the study.~Children who remained afebrile between the 36th and 72nd hour will be considered as responders, and they will proceed into the study.~Patients in the standard treatment arm will continue ancillary treatment and follow-up .~Patients in the investigational treatment arm will enter the tapering phase."

DRUG

Intravenous Immunoglobulins, Human

see previous section

All Listed Sponsors
collaborator

Asst Degli Spedali Civili Di Brescia

OTHER

collaborator

IRCCS Burlo Garofolo

OTHER

lead

Meyer Children's Hospital IRCCS

OTHER