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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014665
Receipt No. R000017058
Scientific Title The investigation of the therapeutic efficacy of rapid intravenous immunoglobulin injection for acute phase Kawasaki disease
Date of disclosure of the study information 2014/07/27
Last modified on 2016/07/28

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Basic information
Public title The investigation of the therapeutic efficacy of rapid intravenous immunoglobulin injection for acute phase Kawasaki disease
Acronym IIKD study
Scientific Title The investigation of the therapeutic efficacy of rapid intravenous immunoglobulin injection for acute phase Kawasaki disease
Scientific Title:Acronym IIKD study
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the therapeutic efficacy of rapid injection of intravenous immunoglobulin for acute phase Kawasaki disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Duration of fever from the initiation of IVIG
Key secondary outcomes ・WBC count and serum CRP, HDL-C and albumin levels before and after IVIG treatment
・Change of coronary artery diameter
・Clinical signs and symptoms, and laboratory blood markers before and after IVIG treatment
・Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Freeze-Dried Sulfonated Human Normal Immunoglobulin 2g/kg (maximum administration rate 0.06ml/kg/min)
Interventions/Control_2 Freeze-Dried Sulfonated Human Normal Immunoglobulin 2g/kg (maximum administration rate 0.03ml/kg/min)
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
15 years-old >=
Gender Male and Female
Key inclusion criteria Kawasaki disease patients who are scheduled IVIG treatment
Key exclusion criteria Patients with hypersensitivity to immunoglobulin.
Patients with cardiac or liver dysfunction.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takaomi Minami
Organization Jichi Medical University
Division name Department of Pediatrics
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498 Japan
TEL 0285-58-7366
Email tminami@jichi.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takaomi Minami
Organization Jichi Medical University
Division name Department of Pediatrics
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498 Japan
TEL 0285-58-7366
Homepage URL
Email tminami@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Touro University California
National Institutes of Health (NIH)
Name of secondary funder(s) Partial support by Teijin Co., Ltd.

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 芳賀赤十字病院 (栃木県)、新小山市民病院(栃木県)、国際医療福祉大学病院(栃木県)、獨協医科大学病院(栃木県)、JCHO宇都宮病院(栃木県)、済生会宇都宮病院 (栃木県)、古河赤十字病院(茨城県)、佐野厚生病院(栃木県)、那須赤十字病院(栃木県)、足利赤十字病院(栃木県)、下都賀総合病院(栃木県)、自治医科大学附属さいたま医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 27 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 30 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
2014 Year 07 Month 27 Day
Last modified on
2016 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017058

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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