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A prospective randomized controlled trial of immunoglobulin plus prednisolone for Kawasaki disease patients with high risk for coronary abnormalities

A prospective randomized controlled trial of immunoglobulin plus prednisolone for Kawasaki disease patients with high risk for coronary abnormalities - A prospective randomized controlled trial of immunoglobulin plus prednisolone for Kawasaki disease patients with high risk for coronary abnormalities

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009524
Enrollment
240
Registered
2012-12-17
Start date
2012-12-17
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

Kawasaki disease

Interventions

Intravenous immunoglobulin (2g/kg) over 24 h with aspirin (30mg/kg/day). The dosage of aspirin can be reduced to 5 mg/kg/day after resolution of fever. Intravenous immunoglobulin (2g/kg) over 24 h plu

Sponsors

Nagoya University Graduate School of Medicine, Department of Pediatrics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Severe Kawasaki disease patients of risk score 4 points or more. 2. Written informed consent is obtained from patients or their parents. 3. Streptococcus, Epstain-Bar virus, adenovirus, or yersinia infection, or measles, or Stevens-Johnson syndrome is ruled out.

Exclusion criteria

Exclusion criteria: 1. Patients with past histories of Kawasaki disease 2. Patients diagnosed as Kawasaki disease on the ninth day of illness or later. 3. Kawasaki disease patients with coronary artery lesions before treatment 4. Kawasaki disease patients with defervescence before treatment 5. Patients given steroids within 28 days before treatment 6. Patients given IVIG within 180 days before treatment 7. Patients with severe underlining diseases 8. Patients with bacterial infection

Design outcomes

Primary

MeasureTime frame
Incidence of coronary artery lesions within 4 weeks after primary treatment

Secondary

MeasureTime frame
Incidence of coronary artery lesions at 4 weeks after primary treatment, Z score of coronary artery diameters, incidence of resistance to primary treatment or relapse, duration of fever after primary treatment, serum concentrations of C-reactive protein at 1 week and 2 weeks after primary treatment, and incidence of adverse events

Countries

Japan

Contacts

Public ContactTaichi Kato

Nagoya University Graduate School of Medicine Department of Pediatrics

ktaichi@med.nagoya-u.ac.jp052-744-2298

Outcome results

None listed

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