UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007133
Receipt No. R000008399
Scientific Title Prospective Observational Study on Stratified Treatment with Immunoglobulin plus Steroid Efficacy and Safety for Kawasaki Disease
Date of disclosure of the study information 2012/02/01
Last modified on 2017/06/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective Observational Study on Stratified Treatment with Immunoglobulin plus Steroid Efficacy and Safety for Kawasaki Disease
Acronym Post RAISE
Scientific Title Prospective Observational Study on Stratified Treatment with Immunoglobulin plus Steroid Efficacy and Safety for Kawasaki Disease
Scientific Title:Acronym Post RAISE
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of treatment by a combination of immunoglobulin, acetylsalicylic acid and prednisolone for severe Kawasaki disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of coronary artery lesions one month after initial treatment
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) 5 or 6 major symptoms of Kawasaki disease
2) 4 major symptoms with 4 or more days of fever
3) 3 major symptoms with 5 or more days of fever
4) 1 or 2 major symptoms with coronary artery lesions
Key exclusion criteria 1)Similar findings are present, but Kawasaki disease is unlikely
2) 4 major symptoms with 3 or less days of fever
3) 3 major symptoms with 4 or less days of fever
4) 1 or 2 major symptoms without coronary artery lesions
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miura
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Cardiology, Department of Clinical Research
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo
TEL 042-300-5111
Email masaru_miura@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohichi Miyata
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Cardiology
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo
TEL 042-300-5111
Homepage URL
Email koichi_miyata@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 都立小児総合医療センター(東京都)、都立広尾病院(東京都)、都立大塚病院(東京都)、都立墨東病院(東京都)、慶應義塾大学病院(東京都)、済生会中央病院(東京都)、国立病院機構東京医療センター(東京都)、荏原病院(東京都)、永寿総合病院(東京都)、多摩北部医療センター(東京都)、多摩南部地域病院(東京都)、公立福生病院(東京都)、共済立川病院(東京都)、日野市立病院(東京都)、川崎市立川崎病院(神奈川県)、横浜市民病院(神奈川県)、けいゆう病院(神奈川県)、横須賀共済病院(神奈川県)、平塚共済病院(神奈川県)、平塚市民病院(神奈川県)、伊勢原協同病院(神奈川県)、国立病院機構埼玉病院(埼玉県)、さいたま市立病院(埼玉県)、総合太田病院(群馬県)、済生会宇都宮病院(栃木県)、国立病院機構栃木医療センター(栃木県)、足利赤十字病院(栃木県)、佐野厚生病院(栃木県)、静岡市立清水病院(静岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 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
2012 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Echocardiography performed on the day before IVIG, 7 (5-9) days, 14 (10-18) days and 30 (20-40) days after IVIG.

Management information
Registered date
2012 Year 01 Month 24 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.