Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone combined with intravenous immunoglobulin (IVIG) as a primary treatment in patients with acute Kawasaki Disease

Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone combined with intravenous immunoglobulin (IVIG) as a primary treatment in patients with acute Kawasaki Disease - Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone with IVIG for acute Kawasaki Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009946

Enrollment

418

Registered

2013-02-20

Start date

2008-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Acute Kawasaki Disease

Interventions

two times administrations of intravenous methylprednisolone pulse combined with the IVIG treatment single administration of intravenous methylprednisolone pulse combined with the IVIG treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) complete Kawasaki disease diagnosed by the japanese diagnostic guidelines for Kawasaki disease 2) fervescece period less than 5 days 3) elder than 3 months of age 4) no previous treatments for Kawasaki disease 5) written informed consent obteined

Exclusion criteria

Exclusion criteria: 1) coronary artery lesions found before treatments 2) addisional underlying diseases other than Kawasaki disease 3) unsuitable patients considered by doctor in charge

Design outcomes

Primary

Measure	Time frame
reduction of fervescence period, improvement of laboratory tests, frequency of adverse events	—

Secondary

Measure	Time frame
frequency and severity of coronary arterial lesions in acute phase and long-term prognosis	—

Countries

Japan

Contacts

Public ContactTetsuya Sano

Osaka Kosei-nenkin Hospital Deaprtment of Pediatrics

sanotet@okn.gr.jp06-6441-5451

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026