UMIN-CTR Clinical Trial

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

Public contact
Name of contact person	1st name Takaomi Middle name Last name Minami
Organization	Jichi Medical University
Division name	Department of Pediatrics
Zip code	329-0498
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	Jichi Medical University
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498 Japan
Tel	0285-44-2111
Email	rinri@jichi.ac.jp

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	Completed
Date of protocol fixation	2014 Year 07 Month 25 Day
Date of IRB	2013 Year 11 Month 22 Day
Anticipated trial start date	2014 Year 10 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 27 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://center6.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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