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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
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 | 2021/01/07 |
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 |
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Condition | ||
Condition | Kawasaki disease | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |