A Randomized Phase III Multicenter Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin Retreatment in Children With Kawasaki Disease Who Did Not Respond to Initial IVIG Treatment

What this Trial Is About

Researchers are studying Kawasaki Disease (KD), a common blood vessel inflammation affecting young children under 5 years old, which can lead to heart problems and rarely early death. This trial focuses on children who did not improve after the usual treatment with intravenous immunoglobulins (IVIG). The study aims to evaluate whether Anakinra, an anti-inflammatory medicine, works better than a second IVIG infusion to reduce fever and inflammation in these patients. Participants are randomly assigned to receive either Anakinra or a second IVIG infusion. Anakinra is given by injection starting at 4 mg/kg, with possible dose increases based on fever response over 14 days. The IVIG group receives standard care with a 2g/kg infusion. Treatment effects on fever, inflammation, disease activity, and heart artery changes are compared between groups. Safety and side effects are closely monitored. During the study, children will have regular clinical exams, temperature checks, and laboratory tests including blood markers of inflammation. Parents will assess disease activity and record symptoms in a follow-up booklet. Heart ultrasounds are done to assess artery health. Monitoring continues up to 60 days to evaluate treatment response, side effects, and heart-related outcomes. The main measure of success is whether fever resolves within 48 hours after starting treatment.

A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment