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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012741
Receipt No. 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

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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
Email 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
Email kimurami@sch.pref.shizuoka.jp

Sponsor
Institute Shizuoka Children's Hospital, Department of Allergy and Clinical Immunology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014887

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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