UMIN-CTR Clinical Trial

Basic information
Public title	Combined therapy with immune-suppressive drug in children with immunoglobulin resistant Kawasaki disease
Acronym	Combined therapy with IFX and CICyA in KD
Scientific Title	Combined therapy with immune-suppressive drug in children with immunoglobulin resistant Kawasaki disease
Scientific Title:Acronym	Combined therapy with IFX and CICyA in KD
Region	Japan

Condition
Condition	Kawasaki disease
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We study that efficacy of combined therapy with infliximab and continuos infusion of cyclosporin A. Combined therapy with infliximab and continuos infusion of cyclosporin A was already started from 2008 in our university. But efficacy of early therapy until day 8 to 9 of illness remain unclear.
Basic objectives2	Others
Basic objectives -Others	We analyze for alteration of expression levels of RNA in white blood cell compared between diagnostic day and day of final therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of coronary artery dilatation until 1 month.
Key secondary outcomes	Evaluation of side effect with combined therapy. Evaluation of alternation of expression levels of RNA.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Until day 8 of illness, imfliximab 5mg/kg (over 1years-old) Until day 9 , continuos infusion of cyclosporin A (2.5-3.0mg/kg/day).
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	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Children (under 15 years-old) with Kawasaki disease at acute phase until day 8 of illness, including incomplete Kawasaki disease. All patients or their parents were informed of the significance and risks of the study and gave their consent according to the rules of our university hospital.
Key exclusion criteria	shock or oversensitivity of asprin, immunoglobulin, infliximab, and cyclosporin A. low contraction at left ventricle (FS<0.28) low renal function (creatinine <0.9mg/dl or estimated GFR<50ml/min/1.73m2) Contraindication of infliximab and cyclosporin A. Liver dysfunction (AST or ALT >500 U/L) before continuos infusion of cyclosporin A. Critical active bacterial infection before therapy.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Miyamoto
Organization	Dokkyo medical university
Division name	Department of pediatrics
Zip code	3210293
Address	Mibu-machi 880, Tochigi-ken
TEL	0282-86-1111
Email	kenmimi@dokkyomed.ac.jp

Public contact
Name of contact person	1st name IRB Middle name Last name IRB
Organization	Dokkyo medical university
Division name	Department of pediatrics
Zip code	3210293
Address	Mibu-machi 880, Tochigi-ken
TEL	0282-86-1111
Homepage URL
Email	r-kenkyu@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo medical university
Institute
Department

Funding Source
Organization	Dokkyo medical university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Dokkyomedical university
Address	Mibu 880, Tochigi, Japan
Tel	0282861111
Email	r-kenkyu@dokkyomed.ac.jp

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	2018 Year 05 Month 01 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	52
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	Terminated
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 03 Month 27 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 04 Day
Last modified on	2019 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036593