UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Kawasaki disease

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Seiji Kojima

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2298

Email

kojimas@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Taichi Kato

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2298

Homepage URL

Email

ktaichi@med.nagoya-u.ac.jp

Institute

Nagoya University Graduate School of Medicine, Department of Pediatrics

Institute

Department

Personal name

Organization

The Morinaga Foundation for Health &
Nutrition

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

09

Month

14

Day

Date of IRB

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

Other related information

Registered date

2012

Year

12

Month

11

Day

Last modified on

2018

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011183