UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000940 |
|---|---|
| Receipt number | R000001126 |
| Scientific Title | Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease |
| Date of disclosure of the study information | 2008/01/27 |
| Last modified on | 2011/05/04 09:11:36 |
* 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
Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease
Acronym
Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease
Scientific Title
Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease
Scientific Title:Acronym
Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implementing a randomized controlled trial to confirm the superiority of the intravenous immunoglobulin (IVIG) and prednisolone combined therapy over the standard IVIG alone therapy in terms of the incidence of coronary artery lesions among severe cases of Kawasaki disease (risk score 5 points or more).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of coronary artery lesions until 1 month after initial treatment
Key secondary outcomes
Incidence of coronary lesions at 1 month after initial treatment, incidence of resistance to initial treatment or relapse, number of days until becoming afebrile, serum levels of C-reactive protein at 1 and 2 weeks after starting treatment, and adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous immunoglobulin (2 g/kg/day) over 24 hours with aspirin (30 mg/kg/day).The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile.
Interventions/Control_2
Intravenous immunoglobulin (2 g/kg/day) over 24 hours with aspirin (30 mg/kg/day). The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile. Intravenous Prednisolone (2 mg/kg/day) will be given for 5 days after starting treatment and then orally until the C-reactive protein levels are 0.5 mg/dL or less. After CRP becomes normal, doses of prednisolone will be tapered over 15 days in 5-day steps (2 mg/kg/day, 1 mg/kg/day, and 0.5 mg/kg/dayfor 5 days, respectively). Famotidine will be administered with prednisolone.
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. Kawasaki disease patients with risk score 5 points or more.
2. Kawasaki disease patients whose written informed consent has been obtained (from them or from their parents).
3. The following Kawasaki disease mimicking diseases will be clinically ruled out: streptococcus, Epstain-Bar virus, adenovirus, or yersinia infection, or measles, or Stevens-Johnson syndrome.
Key exclusion criteria
1. Patients without informed consent to participate in this study.
2. Patients with past histories of Kawasaki disease (recurrent cases).
3. Patients diagnosed on the ninth day of illness or later (the first illness day is defined as the day when the patient develops a fever).
4. Kawasaki disease patients with coronary lesions before starting treatment.
5. Kawasaki disease patients being afebrile before starting treatment.
6. Patients having received steroids (oral, intravenous, intramuscular, or subcutaneous) within a month.
7. Patients having received intravenous immune gamma-globulin infusion.
8. Patients with the following severe diseases: immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.
9. Patients with the following active bacterial infections: sepsis, septic meningitis, peritonitis, bacterial pneumonia, etc.
Target sample size
392
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Saji |
Organization
Toho University Medical Center Omori Hospital
Division name
Department of Pediatrics
Zip code
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Kobayashi |
Organization
Gunma University Grraduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8205
Homepage URL
http://raise.umin.jp
torukoba@nifty.com
Sponsor or person
Institute
Randomized controlled trial to Assess Immunoglobulin plus Steroid Efficacy for Kawasaki disease (RAISE) Study Group
Institute
Department
Personal name
Funding Source
Organization
Minister of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 07 | Day |
Last modified on
| 2011 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001126
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
