UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the usefulness of a new protocol (Shizuoka protocol 2011) for the treatment of Kawasaki disease
Title of the study (Brief title)	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	Mitsuaki Kimura
Organization	Shizuoka Children's Hospital
Division name	Department of Allergy and Clinical Immunology
Address	Shizuoka City, Aoi-ku, Urushiyama 860
TEL	054-247-6251
Email	kimurami@sch.pref.shizuoka.jp

Public contact
Name of contact person	Mitsuaki Kimura
Organization	Shizuoka Children's Hospital
Division name	Department of Allergy and Clinical Immunology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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