UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002032 |
|---|---|
| Receipt number | R000002478 |
| Scientific Title | Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease |
| Date of disclosure of the study information | 2009/06/02 |
| Last modified on | 2013/01/09 17:06:22 |
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Basic information
Public title
Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease
Acronym
Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease
Scientific Title
Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease
Scientific Title:Acronym
Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease
Region
| Japan |
Condition
Condition
Kawasaki Disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of Cyclosporine for refractory Kawasaki disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of coronary artery lesions abnormalities
Key secondary outcomes
Duration of fever under CyA treatment
Duration to normalization of CRP levels
% Neutrophils
Incidence of adverse reaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who do not respond to initial intravenous immunoglobulin (IVIG) (2 g/kg/day) with aspirin (30-50 mg/kg/day) within 48hrs will receive additional IVIG with aspirin.
To patients who do not respond to additional IVIG, 4 mg/kg/ day of Cyclosporine (CyA) will be orally given twice a day before meal. Aspirin(30-50 mg/kg/day) also will be given in three times a day after meal. The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile.
CyA will be given until becoming afebrile and/or CRP normalization for a maximum of 21 days. The dose of CyA can be increased/ decreased within a certain range of CyA level. When CyA trough level is considered to be too low to improve clinical signs, the dose will be increased. On the contrary, when CyA trough level exceeds the limit, the dose will be decreased to be safe. If CyA treatment is ineffective, patients will receive other treatments.
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
| 0 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with Kawasaki disease (KD) who are over 4 months old and under 20 years old
2.Patients nonresponsive to initial IVIG starting before the seventh day of illness and additional IVIG
3. Patients who or whose parents signed informed consent to participate in this study.
Key exclusion criteria
1.Recurrent cases of KD
2.Patients having received initial IVIG on the eighth day or later of illness
3.Patients with coronary artery lesions before starting initial IVIG
4.Patients being afebrile before starting initial IVIG
5.Patients having received steroids and/or immunosuppressive agents within a month
6.Patients having received IVIG within 6 month
7.Patients with drug allergy or idiosyncrasy
8.Patients with other severe diseases
9.Patients with severe hepatic dysfunction when starting CyA therapy.
10.Patients with severe renal dysfunction when starting CyA therapy
11.Patients whose doctors think their participation in this study inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Hata |
Organization
Graduate School of Medicine, Chiba University
Division name
Dept.of Public Health
Zip code
Address
1-8-1,Inohana,chuo-ku,Chiba City, 260-8670,Japan
TEL
043-226-2069
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hata |
Organization
Graduate School of Medicine, Chiba University
Division name
Dept.of Public Health
Zip code
Address
1-8-1, Inohana, chuo-ku, Chiba City 260-8670,Japan
TEL
043-226-2067
Homepage URL
ahata@faculty.chiba-u.jp
Sponsor or person
Institute
Study group for search of susceptibility genes of Kawasaki disease and implementation of genotype-based personalized medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 06 | Month | 02 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 02 | Day |
Last modified on
| 2013 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002478
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
