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Non Inferiority KawasakI Trial With Anakinra

Study acronym: NIKITA
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 6 of 8 entries
    • Collaborators revised (2)
    • Publications: details revised at 8 of 8 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06697431
Lead Sponsor Meyer Children's Hospital IRCCS
Collaborators: Asst Degli Spedali Civili Di Brescia, IRCCS Burlo Garofolo
Conditions
(from sponsor)		 Kawasaki Disease, Anakinra
Related terms Mucocutaneous Lymph Node Syndrome
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov