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Combined therapy with immune-suppressive drug in children with immunoglobulin resistant Kawasaki disease

Combined therapy with immune-suppressive drug in children with immunoglobulin resistant Kawasaki disease - Combined therapy with IFX and CICyA in KD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032096
Enrollment
200
Registered
2018-05-01
Start date
2018-04-01
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

Kawasaki disease

Interventions

Until day 8 of illness, imfliximab 5mg/kg (over 1years-old) Until day 9 , continuos infusion of cyclosporin A (2.5-3.0mg/kg/day).

Sponsors

Dokkyo medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children (under 15 years-old) with Kawasaki disease at acute phase until day 8 of illness, including incomplete Kawasaki disease. All patients or their parents were informed of the significance and risks of the study and gave their consent according to the rules of our university hospital.

Exclusion criteria

Exclusion criteria: shock or oversensitivity of asprin, immunoglobulin, infliximab, and cyclosporin A. low contraction at left ventricle (FS<0.28) low renal function (creatinine <0.9mg/dl or estimated GFR<50ml/min/1.73m2) Contraindication of infliximab and cyclosporin A. Liver dysfunction (AST or ALT >500 U/L) before continuos infusion of cyclosporin A. Critical active bacterial infection before therapy.

Design outcomes

Primary

MeasureTime frame
Prevalence of coronary artery dilatation until 1 month.

Secondary

MeasureTime frame
Evaluation of side effect with combined therapy. Evaluation of alternation of expression levels of RNA.

Countries

Japan

Contacts

Public ContactIRB IRB

Dokkyo medical university Department of pediatrics

r-kenkyu@dokkyomed.ac.jp0282-86-1111

Outcome results

None listed

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