UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005021 |
|---|---|
| Receipt number | R000005970 |
| Scientific Title | Clinical trial of Methyl-prednisolone pulse conbined therapy for Refractory Kawasaki Disease: Trial in Single Institution |
| Date of disclosure of the study information | 2011/02/05 |
| Last modified on | 2011/02/04 09:24:53 |
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Basic information
Public title
Clinical trial of Methyl-prednisolone pulse conbined therapy for Refractory Kawasaki Disease: Trial in Single Institution
Acronym
Clinical trial of sterid pulse conbined therapy for Kawasaki Disease
Scientific Title
Clinical trial of Methyl-prednisolone pulse conbined therapy for Refractory Kawasaki Disease: Trial in Single Institution
Scientific Title:Acronym
Clinical trial of sterid pulse conbined therapy for Kawasaki Disease
Region
| Japan |
Condition
Condition
Kawasaki diease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Approximately 20% of patients with Kawasaki disease (KD) are not responsive to intravenous immunoglobulin (IVIG). Coronary artery lesions frequently develop in refractory KD patient. This study examined the clinical efficacy and safety of a methylprednisolone-plus-IVIG combination therapy (IVMP+IVIG) for the initial treatment of patients with predicted refractory KD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
First outcome defined a antipyretic potency at 36 hours after completion of the initial treatment.
Key secondary outcomes
Second outcome defined a envaluation of coronary artery at 36 hours and 1 month after the end of thrapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
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
Exclusion criteria included a previous diagnosis, the presence of coronary artery aneurysms, and other contraindications to steroid therapy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ishii, Masahiro |
Organization
Kitasato University, School of Medicine
Division name
Pediatrics
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sgamihara
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato university School of Medicine
Division name
Pediatrics
Zip code
Address
1-15-1 Kitasato, Minami-ku Sagamihara
TEL
Homepage URL
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology
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
| 2011 | Year | 02 | Month | 05 | 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 | 01 | 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
his study investigated the clinical efficacy and side effects of initial IVMP+IVIG combination therapy in patients predicted to have IVIG-resistant KD in a prospective, randomized study.
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=R000005970
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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