Macrophage activation syndrome as a complication of Kawasaki disease in children
Collects European data on macrophage activation syndrome in children with Kawasaki disease.
Key facts
- Who runs it
- Meyer Children's Hospital IRCCS
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- MASKd: a Study on Kawasaki Disease (KD) Complicated by Macrophage Activation Syndrome (MAS)
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- Feb 2026
- Expected to end
- Feb 2029
- Type of study
- Observational, 3 groups
- Record updated
- 25 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teens with Kawasaki disease (KD) who also had macrophage activation syndrome (MAS), a severe overreaction of the immune system. It collects data from many centers in Europe. It also includes children with KD who did or did not respond to first-line treatment, as comparison groups.
- Age
- 4 weeks to under 18 years at the time of KD diagnosis
- Sex
- All
- Disease stage
- KD diagnosed according to the 2024 AHA guidelines. MAS diagnosed by the treating doctor within 30 days from the start of KD.
Main reasons for not taking part
- KD diagnosis not confirmed, for example a condition that looks like KD
- Primary (genetic) HLH
- No informed consent given
- MAS diagnosed more than 30 days after or more than 15 days before the start of KD
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- MAS diagnosed more than 30 days after or more than 15 days before the onset of KD
- Unconfirmed diagnosis of KD (e.g., mimicking conditions)
- Primary (genetic) HLH
- Lack of informed consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- MAS-KD patients.
Patients with diagnosis of KD made according to the 2024 AHA guidelines.
- KD-resistant controls
Patients with KD resistant to first-line therapy
- KD-responsive controls
Patients with KD responsive to first-line therapy.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- MACROPHAGE ACTIVATION SYNDROME IN KAWASAKI DISEASE: Features, Treatment, Outcome, Predictive and Diagnostic Factors (The MASKd Study)
- Plain-language title
- Macrophage activation syndrome as a complication of Kawasaki disease in childrenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 25 March 2026