UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009946 |
|---|---|
| Receipt number | 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 09:42:07 |
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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
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
sanotet@okn.gr.jp
Sponsor or person
Institute
the Osaka Kawasaki Dieaase Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011649
