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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002032
Receipt No. 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

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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
Email

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
Email ahata@faculty.chiba-u.jp

Sponsor
Institute Study group for search of susceptibility genes of Kawasaki disease and implementation of genotype-based personalized medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002478

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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