UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014665 |
|---|---|
| Receipt number | 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 | 2021/01/07 18:37:00 |
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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
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
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
tminami@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017058
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