Non Inferiority KawasakI Trial With Anakinra
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-16
SponsorMeyer Children's Hospital IRCCS
About this trial
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.
Eligibility criteria
Qualifiers
bilateral non-purulent conjunctivitis
cervical lymphadenopathy
polymorphous skin rash
changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)
Disqualifiers
To be enrolled children need to show persistent fever ≤7 days
Written informed consent from an appropriate legal representative(s), and assent from patients older than 7 years
Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.
Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)
Trial design
Treatments tested in this trial
- Anakinra
- Intravenous Immunoglobulins, Human
Treatment groups
38 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Meyer Children's Hospital IRCCS
Lead sponsor
Asst Degli Spedali Civili Di Brescia
Collaborator
IRCCS Burlo Garofolo
Collaborator
Source ClinicalTrials.gov