UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032096 |
|---|---|
| Receipt number | 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 17:55:19 |
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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
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
r-kenkyu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036593
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
