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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032096
Receipt No. R000036593
Scientific Title Combined therapy with immune-suppressive drug in children with immunoglobulin resistant Kawasaki disease
Date of disclosure of the study information 2018/05/01
Last modified on 2019/10/06

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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

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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