UMIN-CTR Clinical Trial

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

Kawasaki disease

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

03

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

03

Month

29

Day

Last modified on

2013

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012114