MASKd: a Study on Kawasaki Disease (KD) Complicated by Macrophage Activation Syndrome (MAS)

Starting soon

Conditions studied: Kawasaki Disease, Macrophage Activation Syndrome (MAS)

In brief

Kawasaki Disease (KD) is one of the most common vasculitides in childhood and represents a leading cause of acquired heart disease in developed countries. Macrophage Activation Syndrome (MAS) is a potentially life threatening hyperinflammatory condition belonging to the spectrum of hemophagocytic lymphohistiocytosis (HLH), and it can complicate various rheumatologic diseases. Awareness of MAS in the context of KD has recently increased, supporting the hypothesis that it is an underdiagnosed complication. The study aims to define the epidemiology, clinical characteristics, management, and therapeutic strategies of MAS in patients with KD, through a multicenter data collection in Europe.

Key facts

Study ID

NCT07491926

Run by

Meyer Children's Hospital IRCCS

People needed

150

Starts

2026-02-01

Expected to finish

2029-02-01

Last updated by the study team

2026-03-25

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 4 weeks and under 18 years at the time of KD diagnosis
• Diagnosis of KD made according to the 2024 AHA guidelines
• Diagnosis of MAS made by the attending physician within 30 days from the onset of KD.

You may not qualify if…

• Unconfirmed diagnosis of KD (e.g., mimicking conditions)
• Primary (genetic) HLH
• Lack of informed consent
• MAS diagnosed more than 30 days after or more than 15 days before the onset of KD

Where it is running

• Azienda Ospedaliero-Universitaria IRCCS Meyer — Florence, Italy, Italy

Full record on ClinicalTrials.gov

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