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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010349
Receipt No. R000012114
Scientific Title Dalteparin, a Low Molecular Weight Heparin, as Part of Combination Therapy for Patients with Kawasaki Disease: a Retrospective and Pilot Study
Date of disclosure of the study information 2013/03/29
Last modified on 2013/03/29

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Basic information
Public title Dalteparin, a Low Molecular Weight Heparin, as Part of Combination Therapy for Patients with Kawasaki Disease: a Retrospective and Pilot Study
Acronym Dalteparin in combination therapy for KD
Scientific Title Dalteparin, a Low Molecular Weight Heparin, as Part of Combination Therapy for Patients with Kawasaki Disease: a Retrospective and Pilot Study
Scientific Title:Acronym Dalteparin in combination therapy for KD
Region
Japan

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

Objectives
Narrative objectives1 We assessed whether concurrent dalteparin, which has anti- coagulant and anti-angiogenic activity, would reduce coronary artery lesion (CAL) prevalence and resistance to intravenous immunoglobulin (IVIG) therapy in KD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes A survey of coronary artery lesion (CAL), resistance for intravenous immunoglobulin (IVIG) therapy and additional IVIG therapy was performed within one months of all patients.
Key secondary outcomes A survey of cardiac sequelae was performed using echocardiography at follow-up, within three months of discharge of all patients.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This retrospective study comprised two parts. Subjects with Kawasaki disease (KD) (n = 126), admitted from January 2004 to June 2008, received either dalteparin at 75 IU/kg/h, IVIG at 400 mg/kg/d for 5 d consecutively and aspirin at 30 mg/kg/d, or dalteparin at 75 IU/kg/h and aspirin at 30 mg/kg/d. Control data came from the 2005-06 nationwide KD survey. Subjects with KD (n = 112), admitted from June 2010 to February 2012, received either dalteparin at 75 IU/kg/h, IVIG 2.0 g/kg/d and aspirin at 30 mg/kg/d, or dalteparin at 75 IU/kg/h and aspirin at 30 mg/kg/d. Control data came from the 2009-10 nationwide KD survey. All of the subjects at the single institution were given dalteparin as part of their combination therapy.
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 months-old <=
Age-upper limit
167 months-old >=
Gender Male and Female
Key inclusion criteria The diagnostic criteria are compliant with the Diagnostic Guidelines for Kawasaki Disease (5th revision).
Key exclusion criteria Patients presenting with CAL before the initial treatment were also excluded from the study.
Target sample size 238

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuji Inamo
Organization Nihon University School of Medicine
Division name Department of pediatrics and child health
Zip code
Address 30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL 03-3972-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuji Inamo
Organization Nihon University School of Medicine
Division name Department of pediatrics and child health
Zip code
Address 30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL 03-3972-8111
Homepage URL
Email inamo.yasuji@nihon-u.ac.jp

Sponsor
Institute Department of pediatrics and child health, Nihon University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 旧 日本大学医学部付属練馬光が丘病院小児総合診療科(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 29 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 A comparison of the first trial with the nationwide survey, showed that the rate of initial administration of IVIG was 80.2% versus 86.0%; the rate of additional IVIG administration was 7.1% versus 14.0% (P < 0.03); the prevalence of CAL in the acute period was 4.8% versus 11.9% (P < 0.01); and the prevalence of cardiovascular sequelae was 0% versus 3.8% (P < 0.05). A comparison of the second trial with the nationwide survey, showed that the rate of initial administration of IVIG was 92.9% versus 89.5%; the rate of additional IVIG administration was 8.9% versus 17.1% (P < 0.02); the prevalence of resistance to IVIG was 3.6% versus 14.9% (P < 0.001); and the prevalence of CAL in the acute period was 2.7% versus 8.6% (P < 0.03).
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
2004 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 20 Day
Date trial data considered complete
2012 Year 12 Month 20 Day
Date analysis concluded
2012 Year 12 Month 20 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 29 Day
Last modified on
2013 Year 03 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012114

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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