UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000028001