Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease

UMIN ID: UMIN000000940

Registered date:27/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Kawasaki disease
• Date of first enrollment: 2008/09/01
• Target sample size: 392
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intravenous immunoglobulin (2 g/kg/day) over 24 hours with aspirin (30 mg/kg/day).The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile.
Intravenous immunoglobulin (2 g/kg/day) over 24 hours with aspirin (30 mg/kg/day). The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile. Intravenous Prednisolone (2 mg/kg/day) will be given for 5 days after starting treatment and then orally until the C-reactive protein levels are 0.5 mg/dL or less. After CRP becomes normal, doses of prednisolone will be tapered over 15 days in 5-day steps (2 mg/kg/day, 1 mg/kg/day, and 0.5 mg/kg/dayfor 5 days, respectively). Famotidine will be administered with prednisolone.

Outcome(s)

• Primary Outcome: Incidence of coronary artery lesions until 1 month after initial treatment
• Secondary Outcome: Incidence of coronary lesions at 1 month after initial treatment, incidence of resistance to initial treatment or relapse, number of days until becoming afebrile, serum levels of C-reactive protein at 1 and 2 weeks after starting treatment, and adverse events.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients without informed consent to participate in this study. 2. Patients with past histories of Kawasaki disease (recurrent cases). 3. Patients diagnosed on the ninth day of illness or later (the first illness day is defined as the day when the patient develops a fever). 4. Kawasaki disease patients with coronary lesions before starting treatment. 5. Kawasaki disease patients being afebrile before starting treatment. 6. Patients having received steroids (oral, intravenous, intramuscular, or subcutaneous) within a month. 7. Patients having received intravenous immune gamma-globulin infusion. 8. Patients with the following severe diseases: immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc. 9. Patients with the following active bacterial infections: sepsis, septic meningitis, peritonitis, bacterial pneumonia, etc.

Related Information

• Primary Sponsor: Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease (RAISE) Study Group
• Source(s) of Monetary Support: Minister of Health, Labour and Welfare