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Non Inferiority KawasakI Trial With Anakinra
Sponsor: Meyer Children's Hospital IRCCS
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.
Official title: A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra
Key Details
Gender
All
Age Range
1 Month - 16 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2025-04-01
Completion Date
2027-04-01
Last Updated
2024-11-21
Healthy Volunteers
No
Conditions
Interventions
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.
Intravenous Immunoglobulins, Human
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