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Comparison of 10% Immunoglobulin Dosing Times for Kawasaki Disease

A Multicenter Cluster Randomized Crossover Comparison of Dosing Times for a 10% Immunoglobulin for the Treatment of Kawasaki Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041230181
Enrollment
560
Registered
2024-03-29
Start date
2024-03-29
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki Disease Kawasaki disease

Interventions

Dosing time of immunoglobulin

Sponsors

Sato Yoshiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Children with a fever of 37.5 degrees or higher who have been diagnosed with Kawasaki disease. In addition, children who have relapsed 180 days after the last globulin administration are also eligible. 2) Children who have not started initial treatment. (15 years of age or younger)

Exclusion criteria

Exclusion criteria: CAL at the start of treatment, history of steroids within 30 days and immunoglobulin within 180 days of starting treatment

Design outcomes

Primary

MeasureTime frame
Percentage of cases with fever resolution within 24 hours of starting immunoglobulin therapy

Secondary

MeasureTime frame
Time from start of first IVIG administration to fever resolution, number of patients requiring 2nd line therapy, time from initial IVIG to 2nd line therapy, frequency of initial treatment failure and relapse, side effects of IVIG, frequency of CAL complications within 28 days and at 28 days (+7 days or -7 days) of treatment

Contacts

Public ContactYoshiaki Sato

Nagoya University Hospital

yoshiaki@med.nagoya-u.ac.jp+81-52-744-2294

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026