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Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease

Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease - Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002032
Enrollment
30
Registered
2009-06-02
Start date
2008-05-01
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

Patients who do not respond to initial intravenous immunoglobulin (IVIG) (2 g/kg/day) with aspirin (30-50 mg/kg/day) within 48hrs will receive additional IVIG with aspirin. To patients who do not r

Sponsors

Study group for search of susceptibility genes of Kawasaki disease and implementation of genotype-based personalized medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with Kawasaki disease (KD) who are over 4 months old and under 20 years old 2.Patients nonresponsive to initial IVIG starting before the seventh day of illness and additional IVIG 3. Patients who or whose parents signed informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Recurrent cases of KD 2.Patients having received initial IVIG on the eighth day or later of illness 3.Patients with coronary artery lesions before starting initial IVIG 4.Patients being afebrile before starting initial IVIG 5.Patients having received steroids and/or immunosuppressive agents within a month 6.Patients having received IVIG within 6 month 7.Patients with drug allergy or idiosyncrasy 8.Patients with other severe diseases 9.Patients with severe hepatic dysfunction when starting CyA therapy. 10.Patients with severe renal dysfunction when starting CyA therapy 11.Patients whose doctors think their participation in this study inappropriate

Design outcomes

Primary

MeasureTime frame
Incidence of coronary artery lesions abnormalities

Secondary

MeasureTime frame
Duration of fever under CyA treatment Duration to normalization of CRP levels % Neutrophils Incidence of adverse reaction

Countries

Japan

Contacts

Public ContactAkira Hata

Graduate School of Medicine, Chiba University Dept.of Public Health

ahata@faculty.chiba-u.jp043-226-2067

Outcome results

None listed

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