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

UMIN ID: UMIN000002032

Registered date:02/06/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Kawasaki Disease
• Date of first enrollment: 2008/05/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 respond to additional IVIG, 4 mg/kg/ day of Cyclosporine (CyA) will be orally given twice a day before meal. Aspirin(30-50 mg/kg/day) also will be given in three times a day after meal. The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile. CyA will be given until becoming afebrile and/or CRP normalization for a maximum of 21 days. The dose of CyA can be increased/ decreased within a certain range of CyA level. When CyA trough level is considered to be too low to improve clinical signs, the dose will be increased. On the contrary, when CyA trough level exceeds the limit, the dose will be decreased to be safe. If CyA treatment is ineffective, patients will receive other treatments.

Outcome(s)

• Primary Outcome: Incidence of coronary artery lesions abnormalities
• Secondary Outcome: Duration of fever under CyA treatment Duration to normalization of CRP levels % Neutrophils Incidence of adverse reaction

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 20years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Study group for search of susceptibility genes of Kawasaki disease and implementation of genotype-based personalized medicine
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare