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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005021
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kitasato University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005970

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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