UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012741 |
|---|---|
| Receipt number | R000014887 |
| Scientific Title | Evaluation of the usefulness of a new protocol (Shizuoka protocol 2011) for the treatment of Kawasaki disease |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2017/01/06 15:15:47 |
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Basic information
Public title
Evaluation of the usefulness of a new protocol (Shizuoka protocol 2011) for the treatment of Kawasaki disease
Acronym
Treatment of Kawasaki disease by a Shizuoka protocol 2011
Scientific Title
Evaluation of the usefulness of a new protocol (Shizuoka protocol 2011) for the treatment of Kawasaki disease
Scientific Title:Acronym
Treatment of Kawasaki disease by a Shizuoka protocol 2011
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with Kawasaki disease who were resisitant to the first IVIG (2g/kg), a standard first line therapy for Kawasaki disease, and showed higher CRP levels than 10mg/dl after first IVIG were related to a failure in the second line therapy with IVIG alone, and a higher incidence of chronic coronary arterial lesions (CAL). In this study, these patients are treated with IVIG (2g/kg) in combination with prednisolone (2mg/kg) (intensified therapy) as the second line therapy to subside the inflammation as quickly as possible and decrease the incidence of chronic CALs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quick subsidence of inflammation
Key secondary outcomes
Decrease in the incidenece of chronic CALs
Base
Study type
Interventional
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
An intensified second line therapy group:
patients who did not respond to a standard first line therapy with IVIG (2g/kg) and showed post-IVIG CRP levels higher than 10mg/dl are treated with the second IVIG (2g/kg) in combination with prednisolone (2mg/kg/d)
Interventions/Control_2
A conventional second line therapy group:
patients who did not respond to a standard first line therapy with IVIG but showed lower post-IVIG CRP levels than 10mg/dl are treated with the second IVIG alone
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Kawasaki disease diagnostic criteria 4/6 or more
Key exclusion criteria
Kawasaki disease diagnostic criteria less than 4/6
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Kimura |
Organization
Shizuoka Children's Hospital
Division name
Department of Allergy and Clinical Immunology
Zip code
Address
Shizuoka City, Aoi-ku, Urushiyama 860
TEL
054-247-6251
kimurami@sch.pref.shizuoka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Kimura |
Organization
Shizuoka Children's Hospital
Division name
Department of Allergy and Clinical Immunology
Zip code
Address
Shizuoka City, Aoi-ku, Urushiyama 860
TEL
054-247-6251
Homepage URL
kimurami@sch.pref.shizuoka.jp
Sponsor or person
Institute
Shizuoka Children's Hospital, Department of Allergy and Clinical Immunology
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Children's Hospital, Department of Allergy and Clinical Immunology
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
| 2014 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Background: Prednisolone (PSL) has been suggested to be useful for the treatment of patients with Kawasaki disease (KD) resistant to intravenous immunoglobulin (IVIG). However, much remains to be elucidated regarding its proper use.
Methods: Two-stage multicenter prospective studies involving 1,087 subjects were performed to study the effects of acute phase therapy on IVIG-resistant KD. Subjects resistant to the first dose of IVIG were classified into high (>=10 mg/dL) and low (< 10 mg/dL) CRP groups according to serum CRP levels after the first dose of IVIG.
Results: In the first study, the effect of the second dose of IVIG in the high CRP group was significantly lower than that in the low CRP group (47.8 vs. 76.8%, p < 0.005). In the second study, PSL was co-administered with the second dose of IVIG to patients of the high CRP group (intensified regimen). The efficacy of the intensified regimen was comparable to that of the second dose of IVIG in the low CRP group (79.4 vs. 83.3%). Although the difference in the incidence of persistent coronary artery lesion (CAL) between the high and low CRP groups was significant in the first study (19.6 vs. 3.0%, p < 0.005), it was not significant in the second study (8.8 vs. 2.4%).
Conclusions: This study suggests the effectiveness of targeted use of PSL with the second dose of IVIG to KD patients who are resistant to the first dose of IVIG and are predicted to be resistant to the second dose of IVIG.
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
| 2011 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 01 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014887
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