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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025707
Receipt No. R000029505
Scientific Title Study of the efficacy of the acute phase therapy for Kawasaki disease based on a new Shizuoka protocol 2016
Date of disclosure of the study information 2017/02/01
Last modified on 2019/04/02

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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