NIPH Clinical Trials Search

UMIN ID: UMIN000000940

Registered date:27/01/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedKawasaki disease
Date of first enrollment2008/09/01
Target sample size392
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeIncidence of coronary artery lesions until 1 month after initial treatment
Secondary OutcomeIncidence 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 minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name Tohru Kobayashi
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan Japan
Telephone 027-220-8205
Affiliation Gunma University Grraduate School of Medicine Department of Pediatrics
scientific contact
Name Tsutomu Saji
Address 6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan Japan
Telephone 03-3762-4251
Affiliation Toho University Medical Center Omori Hospital Department of Pediatrics