UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005022 |
|---|---|
| Receipt number | R000005971 |
| Scientific Title | a methylprednisolone-plus-intravenous immunoglobulin combination therapy for Refractory Kawasaki Disease |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2011/02/04 09:53:00 |
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Basic information
Public title
a methylprednisolone-plus-intravenous immunoglobulin combination therapy for Refractory Kawasaki Disease
Acronym
Steroid-pulse combination therapy of refractory Kawasaki disease
Scientific Title
a methylprednisolone-plus-intravenous immunoglobulin combination therapy for Refractory Kawasaki Disease
Scientific Title:Acronym
Steroid-pulse combination therapy of refractory Kawasaki disease
Region
| Japan |
Condition
Condition
refractory Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
refractory Kawasaki disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ersistent or recrudescent fever
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
intravenous immunoglobulin therapy
Interventions/Control_2
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
| 3 | months-old | <= |
Age-upper limit
| 120 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients were Japanese and fulfilled the Criteria for Diagnostic Guidelines for Kawasaki Disease (5th revision) published by the Kawasaki Disease Research Committee in Japan
Key exclusion criteria
a previous diagnosis, the presence of coronary artery aneurysms, and other contraindications to steroid therapy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Ishii |
Organization
Kitasato university Kawasaki disease research group
Division name
Kitasato University
Zip code
Address
1-15-1 Kitasato Sagamihara Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato university Kawasaki disease research
Division name
Kitasato University
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Masahiro Ishii
Institute
Department
Personal name
Funding Source
Organization
the Kawasaki Disease Research Center in Japan.
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 11 | 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
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 04 | Day |
Last modified on
| 2011 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005971
