UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039141
Receipt number R000044643
Scientific Title High-dose versus low-dose intravenous immunoglobulin for treatment of children with Kawasaki disease weighing 25 kg or more
Date of disclosure of the study information 2020/01/13
Last modified on 2020/01/13 23:35:47

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Basic information

Public title

High-dose versus low-dose intravenous immunoglobulin for treatment of children with Kawasaki disease weighing 25 kg or more

Acronym

OLDERKD

Scientific Title

High-dose versus low-dose intravenous immunoglobulin for treatment of children with Kawasaki disease weighing 25 kg or more

Scientific Title:Acronym

OLDERKD

Region

Japan


Condition

Condition

Patients who were diagnosed with Kawasaki Disease (KD) (ICD-10 codes M303) between September 2010 and September 2017.
Of these, we included patients who weighed 25 kg and more than 25kg and who received 1 g/kg and more than 1g/kg IVIG within 5 days of their initial hospital admission for KD.
We divided the remaining cases into two groups of patients treated initially with 2 g/kg or 1 g/kg IVIG within 3 days, respectively.

Classification by specialty

Medicine in general Cardiology Pediatrics
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to compare the outcomes in terms of the proportions of coronary artery abnormalities, Intravenous immunoglobulin (IVIG) resistance, length of stay, adverse effects of IVIG, and medical costs between children with KD weighing 25 kg and more than 25kg treated with either 1 g/kg or 2 g/kg IVIG, using information from a Japanese national inpatient database.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome was CAA at the time of discharge in the two groups. CAA was defined as the use of warfarin, clopidogrel, or receipt of cardiac catheterization, in addition to a diagnosis of CAA in the database.

Key secondary outcomes

Secondary outcomes were the proportions of IVIG resistance, length of stay, medical costs, and IVIG-related side effects. IVIG resistance was defined as receiving IVIG at a total dose of 2.5 g/kg or more than 2.5 g/kg at intervals of more than 6 days. Additional treatments were defined as use of corticosteroids after day 5 at initial IVIG treatment, infliximab, plasma exchange, and cyclosporine. We also examined side effects attributed to IVIG treatments.


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

children with KD weighing 25 kg and more treated with 1 g/kg IVIG

Interventions/Control_2

children with KD weighing 25 kg and more treated with 2 g/kg IVIG

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

We identified patients in the database who were diagnosed with KD (ICD-10 codes M303) between September 2010 and September 2017.Of these, we included patients who weighed 25 kg and more and who received 1 g/kg and more IVIG within 5 days of their initial hospital admission for KD.

Key exclusion criteria

Patients with atypical KD and who did not use IVIG within 5 days.

Target sample size

1300


Research contact person

Name of lead principal investigator

1st name Nobuaki
Middle name
Last name Michihata

Organization

The University of Tokyo

Division name

Department of Health Services Research, Graduate School of Medicine

Zip code

157-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.

TEL

+81-3-5841-1887

Email

michihata-tky@umin.org


Public contact

Name of contact person

1st name Nobuaki
Middle name
Last name Michihata

Organization

The University of Tokyo

Division name

Department of Health Services Research, Graduate School of Medicine

Zip code

157-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.

TEL

+81-3-5841-1887

Homepage URL


Email

michihata-tky@umin.org


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

the Ministry of Health, Labour and Welfare, Japan and the Ministry of Education, Culture, Sports, Science and Technology, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office for Human Research Studies(OHRS)

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.

Tel

+81-3-5841-0818

Email

ethics@m.u-tokyo.ac.jp


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

2020 Year 01 Month 13 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044643

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044643

Number of participants that the trial has enrolled

1134

Results

We identified 1134 patients with KD.

Results date posted

2020 Year 01 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The participants who received 2 g/kg IVIG and 198 patients who received 1 g/kg IVIG as an initial treatment. Propensity score matching created 788:197 (4:1) pairs.

Participant flow

A total of 788:197 (4:1) propensity score-matched pairs were created between the 2 g/kg and 1 g/kg IVIG groups.

Adverse events

One patient in the IVIG 2 /kg group developed acute coronary syndrome and no patients were diagnosed with hyperviscosity syndrome.

Outcome measures

There were no significant differences between the 2 g/kg and 1 g/kg IVIG groups in terms of the proportions of CAA (5.3% vs. 4.1%, respectively; p=0.587), IVIG resistance (20.3% vs. 14.2%, respectively; p=0.054), and length of stay (12.6 days vs. 13.6 days, respectively; p=0.206). Medical costs were significantly higher in the 2 g/kg compared with the1 g/kg group (12,754 USD vs. 8920 USD, respectively; p<0.001). The numbers of side effects of IVIG were too small to be compared.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 07 Month 01 Day

Date of IRB

2018 Year 06 Month 13 Day

Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2017 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 13 Day

Last modified on

2020 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044643


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name