Not Yet RecruitingPhase 4

Non Inferiority KawasakI Trial With Anakinra

38 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range1 Month – 16 Years

SexALL

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Inclusion criteria

✓. KD defined in at least one of the three following ways as per American Heart Association (AHA) criteria: Fever for at least 5 days in addition to 4 of the following 5 clinical criteria:
✓. less than 5 days of fever but all 5 clinical criteria above
✓. incomplete KD cases defined as:

Exclusion criteria

✕. 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)
✕. History or evidence of any previous heart disease
✕. Known hypersensitivity to anakinra, IVIG and ASA or any medical condition that contraindicates the use of these treatments
✕. Patients with KD receiving IVIG, corticosteroids, immunosuppressants, biologic treatments at the time of screening

What they're measuring

Number of patients with treatment response in both treatment arms

Timeframe: 12 months

Number of patients with CAA (as per Z-scores) at the end of the study period in both treatment arms

Timeframe: 12 months

Trial details

NCT IDNCT06697431

SponsorMeyer Children's Hospital IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Gabriele Simonini, Prof

0555662913 gabriele.simonini@unifi.it

View on ClinicalTrials.gov More Kawasaki Disease trials