Clinical Trial

Non Inferiority KawasakI Trial With Anakinra

Study acronym: NIKITA
Not Yet Recruiting Phase 4
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Record status
This record was last updated November 21, 2024 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-18.
Trial Details
NCT Number NCT06697431
Lead Sponsor Meyer Children's Hospital IRCCS
Collaborators: Asst Degli Spedali Civili Di Brescia, IRCCS Burlo Garofolo
Conditions Kawasaki Disease, Anakinra
Enrollment 38 participants
Start Date 2025-04-01
Primary Completion 2026-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-21