UMIN-CTR Clinical Trial

Basic information
Public title	Study of the efficacy of the acute phase therapy for Kawasaki disease based on a new Shizuoka protocol 2016
Acronym	Multicenter Study of the therapy for Kawasaki disease by Shizuoka protocol 2016
Scientific Title	Study of the efficacy of the acute phase therapy for Kawasaki disease based on a new Shizuoka protocol 2016
Scientific Title:Acronym	Multicenter Study of the therapy for Kawasaki disease by Shizuoka protocol 2016
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the best way for the treatment of acute phase Kawasaki disease, the effictiveness of three protocols (2016 A,B,C) composed of 3 major drugs, intravenous immunoglobulin (IVIG), prednisolone (PSL), and infliximab (IFX), in various combinations is compared directly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effectiveness is estimated by the incidence of CAL one month after onset.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A subject is treated with IVIG at the 1st step. If the subject is resistant to the 1st IVIG, 2nd IVIG is administered at the 2nd step. In case the subject is predicted to be resistant to the 2nd IVIG (the serum CRP level after 1st IVIG is 7mg/dL or higher), a combination of 2nd IVIG plus PSL is administered.
Interventions/Control_2	A subject is treated with IVIG at the 1st step. If the subject is resistant to the 1st IVIG, 2nd IVIG is administered at the 2nd step. In case the subject is predicted to be resistant to the 2nd IVIG (the serum CRP level after 1st IVIG is 7mg/dL or higher), IFX is administered at the 2nd step.
Interventions/Control_3	A subject is treated with IVIG at the 1st step. If the subject is predicted to be resistant to the 1st IVIG (Kobayashi score is 5 or higher), a combination of 1st IVIG plus PSL is administered at the 1st step.
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	0 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as Kawasaki disease and agree to participate in this study
Key exclusion criteria	Patients who are diagnosed as Kawasaki disease but refuse to participate in this study.
Target sample size	500

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Satoru Iwashima
Organization	Chutoen Central Medical Center
Division name	Department of Pediatrics
Zip code
Address	Syobugaike 1-1, Kakegawa City, Shizuoka
TEL	0537-21-5555
Email	iwashima3617@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Satoru Iwashima
Organization	Chutoen Central Medical Center
Division name	Department of Pediatrics
Zip code
Address	Syobugaike 1-1, Kakegawa City, Shizuoka
TEL	0537-21-5555
Homepage URL
Email	iwashima3617@gmail.com

Sponsor
Institute	Shizuoka Kawasaki Disease Study Group
Institute
Department

Funding Source
Organization	No funding sources
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB	2016 Year 10 Month 28 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 17 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029505