UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective randomized controlled trial of immunoglobulin plus prednisolone for Kawasaki disease patients with high risk for coronary abnormalities
Title of the study (Brief title)	A prospective randomized controlled trial of immunoglobulin plus prednisolone for Kawasaki disease patients with high risk for coronary abnormalities
Region	Japan

Condition
Condition	Kawasaki disease
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We assess safety and efficacy of prednisolone plus immunoglobulin as primary treatment for Kawasaki disease patients with high risk for coronary abnormalities.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Incidence of coronary artery lesions within 4 weeks after primary treatment
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	Intravenous immunoglobulin (2g/kg) over 24 h plus intravenous prednisolone (2mg/kg/day) with aspirin (30mg/kg/day). The dosage of aspirin can be reduced to 5 mg/kg/day after resolution of fever. Prednisolone will be given intravenously for 3 days at least and then can be given orally after resolution of fever. When concentration of C-rective protein becomes 1.0mg/dL or less, the dose of prednisolone will be tapered over 9 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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
Target sample size	240

Research contact person
Name of lead principal investigator	Seiji Kojima
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pediatrics
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2298
Email	kojimas@med.nagoya-u.ac.jp

Public contact
Name of contact person	Taichi Kato
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pediatrics
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2298
Homepage URL
Email	ktaichi@med.nagoya-u.ac.jp

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

Funding Source
Organization	The Morinaga Foundation for Health & Nutrition
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 14 Day
Anticipated trial start date	2012 Year 12 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 12 Month 11 Day
Last modified on	2018 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011183