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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024311
Receipt No. R000028001
Scientific Title Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Date of disclosure of the study information 2016/10/06
Last modified on 2019/04/09

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Basic information
Public title Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Acronym Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Scientific Title Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Scientific Title:Acronym Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effect of clarithromycin for Kawasaki disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse rate of Kawasaki disease (at 4 weeks after treatment)
Key secondary outcomes 1. Rate of initial treatment failure and recurrence
2. Duration of hospitalization
3. Rate of patient who required additional treatment for Kawasaki disease
4. Period of time between defervescence to relapse
5. Laboratory data (WBC count, %neutrophil, %lymphocyte, %eosinophil, hemoglobin, hematocrit, plt count, TP, Alb, T-Bil, AST, ALT, LDH, Na, BUN, Cr, CRP, sICAM-1, sVCAM-1, IL-6, MIG, TNF-R1, TNF-R2)
6. Maximum coronary z score at week 4, change in z score from baseline to week 4
7. Incidence of coronary artery abnormality
8. Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Experimental:
Clarithromycin plus intravenous immunoglobulin (IVIG)
Drug:
Clarithromycin 10 mg/kg/day, po (at least 14 days), IVIG 2 g/kg/day, iv, aspirin 30mg/kg/day (3-5 mg/kg/day after defervescence)
Interventions/Control_2 Placebo Comparator:
Placebo plus IVIG
Drug:
Placebo PO (at least 14 days, same volume as active drug), IVIG 2 g/kg/day, aspirin 30mg/kg/day (3-5 mg/kg/day after defervescence)
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
4 months-old <=
Age-upper limit
72 months-old >
Gender Male and Female
Key inclusion criteria 1.Newly diagnosed Kawasaki disease patients between 4 months and 5 years old.
2.Febrile patient at enrollment.
3.Patients whose written informed consent has been obtained (from them or from their parents).
Key exclusion criteria 1.Patients with day 9 of illness or over, when day 1 defined as the first day of fever.
2.Those have received 14/15-membered ring macrolide.
3.Those with coronary artery abnormality at enrollment.
4.Relapse or recurrence of Kawasaki disease.
5.Those with suspicious origin of fever in addition to Kawasaki disease.
6.Those received intravenous immunoglobulin therapy within 90 days before enrollment.
7.Those with severe underlying disease.
8.Those who are receiving systemic immunosuppressant agent such as steroids at the enrollment.
9.Those with prolonged QT interval.
10.Those with a history of hypersensitivity reactions to macrolides.
11.Those who are receiving drugs which interact with clarithromycin
12.Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Toshiro
Middle name
Last name Hara
Organization Fukuoka Children's Hospital
Division name President
Zip code 813-0017
Address 5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, Japan
TEL 092-682-7000
Email harat@pediatr.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Furuno
Organization Fukuoka Children's Hospital
Division name General pediatrics
Zip code 813-0017
Address 5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, Japan
TEL 092-682-7000
Homepage URL
Email furuno.k@kd-research.com

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukuoka Children's Hospital
Address 5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, Japan
Tel 092-682-7000
Email furuno.k@kd-research.com

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 福岡市立こども病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 06 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 250
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 Completed
Date of protocol fixation
2016 Year 09 Month 06 Day
Date of IRB
2016 Year 12 Month 08 Day
Anticipated trial start date
2016 Year 12 Month 09 Day
Last follow-up date
2018 Year 10 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
2016 Year 10 Month 06 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028001

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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