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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039141
Enrollment
1300
Registered
2020-01-13
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

children with KD weighing 25 kg and more treated with 1 g/kg IVIG children with KD weighing 25 kg and more treated with 2 g/kg IVIG

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactNobuaki Michihata

The University of Tokyo Department of Health Services Research, Graduate School of Medicine

michihata-tky@umin.org+81-3-5841-1887

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026