UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007133 |
|---|---|
| Receipt number | 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 12:18:14 |
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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
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
masaru10miura@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008399
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