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Name:
UMIN ID:

Recruitment status Completed
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 2020/12/16

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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 Masaru
Middle name
Last name Miura
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Cardiology, Department of Clinical Research
Zip code 1838561
Address 2-8-29, Musashidai, Fuchu
TEL 0423005111
Email masaru10miura@gmail.com

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Miyata
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Cardiology
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu, Tokyo
TEL 0423005111
Homepage URL
Email masaru10miura@gmail.com

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 Tokyo Metropolitan Children's Medical Center
Address 2-8-29, Musashidai, Fuchu
Tel 0423005111
Email masaru10miura@gmail.com

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 https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(18)30293-1/fulltext
Publication of results Published

Result
URL related to results and publications https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(18)30293-1/fulltext
Number of participants that the trial has enrolled 2648
Results From July 1, 2012, to June 30, 2015, we enrolled 2628 patients with Kawasaki disease, of whom 724 were predicted IVIG non-responders who received IVIG plus prednisolone as primary treatment. 132 of 724 patients did not respond to primary treatment. Among patients with complete data, coronary artery abnormalities were present in 40 (incidence rate 5.9%, 95% CI 4.3-8.0) of 676 patients according to the AHA criteria or in 26 (3.8%, 2.5-5.6) of 677 patients according to the Japanese criteria.
Results date posted
2020 Year 12 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 10 Month 15 Day
Baseline Characteristics Patients with Kawasaki disease including incomplete type
Participant flow We did a multicentre, prospective cohort study at 34 hospitals in Japan. We included patients diagnosed with Kawasaki disease according to the Japanese diagnostic criteria, and excluded those who were treated at other hospitals before being transferred to a participating hospital.
Adverse events Serious adverse events were reported in 12(1.7%) of 724 patients treated with primary IVIG plus prednisolone; two of these patients had hypertension and bacteraemia that was probably related to prednisolone. One patient died possibly due to severe inflammation from the Kawasaki disease itself.
Outcome measures The primary endpoint was the incidence of coronary artery abnormalities determined by two-dimensional echocardiography at 1 month after the primary treatment in predicted non-responders treated with primary IVIG plus prednisolone. Coronary artery abnormalities were defined according to the criteria of the Japanese Ministry of Health and Welfare and of the American Heart Association (AHA).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 16 Day
Date of IRB
2011 Year 09 Month 01 Day
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
2020 Year 12 Month 16 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


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