UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025707 |
|---|---|
| Receipt number | 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 12:37:18 |
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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
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
iwashima3617@gmail.com
Sponsor or person
Institute
Shizuoka Kawasaki Disease Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029505
