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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009946
Receipt No. R000011649
Scientific Title Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone combined with intravenous immunoglobulin (IVIG) as a primary treatment in patients with acute Kawasaki Disease
Date of disclosure of the study information 2013/02/20
Last modified on 2014/08/04

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Basic information
Public title Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone combined with intravenous immunoglobulin (IVIG) as a primary treatment in patients with acute Kawasaki Disease
Acronym Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone with IVIG for acute Kawasaki Disease
Scientific Title Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone combined with intravenous immunoglobulin (IVIG) as a primary treatment in patients with acute Kawasaki Disease
Scientific Title:Acronym Prospective multicenter trial to assess the effectiveness and safety of pulse methylprednisolone with IVIG for acute Kawasaki Disease
Region
Japan

Condition
Condition Acute Kawasaki Disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of pulse methylprednisolone combined with IVIG as a primary treatment for acute Kawasaki disease compared with standard IVIG treatment alone in the prospective controlled multicenter trial
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes reduction of fervescence period, improvement of laboratory tests, frequency of adverse events
Key secondary outcomes frequency and severity of coronary arterial lesions in acute phase and long-term prognosis

Base
Study type

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 two times administrations of intravenous methylprednisolone pulse combined with the IVIG treatment
Interventions/Control_2 single administration of intravenous methylprednisolone pulse combined with the IVIG treatment
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
3 months-old <=
Age-upper limit
180 months-old >=
Gender Male and Female
Key inclusion criteria 1) complete Kawasaki disease diagnosed by the japanese diagnostic guidelines for Kawasaki disease
2) fervescece period less than 5 days
3) elder than 3 months of age
4) no previous treatments for Kawasaki disease
5) written informed consent obteined
Key exclusion criteria 1) coronary artery lesions found before treatments
2) addisional underlying diseases other than Kawasaki disease
3) unsuitable patients considered by doctor in charge
Target sample size 418

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Sano
Organization Osaka Kosei-nenkin Hospital
Division name Department of Pediatrics
Zip code
Address 4-2-78 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL 06-6441-5451
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Sano
Organization Osaka Kosei-nenkin Hospital
Division name Deaprtment of Pediatrics
Zip code
Address 4-2-78 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL 06-6441-5451
Homepage URL
Email sanotet@okn.gr.jp

Sponsor
Institute the Osaka Kawasaki Dieaase Study Group
Institute
Department

Funding Source
Organization the Osaka Kawasaki Dieaase Study Group
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 02 Month 20 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 No longer recruiting
Date of protocol fixation
2008 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 08 Month 31 Day
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 04 Day
Last modified on
2014 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011649

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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