NCT06697431

Non Inferiority KawasakI Trial With Anakinra

A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter national, open label, randomized, controlled, interventional trial followed by a long-term observational extension period. This is a non-inferiority study Patients who fulfill the eligibility criteria and whose parent/carer (legal representative) has provided informed consent 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) PLUS Aspirin (ASA) 50mg/kg QID until 36 hours from fever disappearance, then switched to low-dose (3-5 mg/Kg once a day) as per standard of care

Conditions

• Kawasaki Disease
• Anakinra

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-11-20
• Last updated: 2024-11-21