Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease
- Conditions
- Severe Kawasaki disease
- Registration Number
- JPRN-UMIN000017585
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 172
Not provided
1)A history of KD recurrence. 2)CAAs prior to enrolment. 3)No presence of fever prior to enrolment. 4)Suspicion that the symptoms may correspond to a disease other than KD. (haemolytic streptococcal infection, EB virus infection, Yersinia infection, measles or Stevens-Johnson syndrome.) 5)Initiation of IVIG treatment later than 9 days after disease onset. 6)Administration of IVIG within 180 days prior to obtaining informed consent. 7)Treatment with steroids (except external preparations), steroid pulse, biological agents, neutrophil elastase inhibitors, immunosuppressants, or plasmapheresis within 30 days of screening. 8)History of hypersensitivity to CsA preparations, immunoglobulin preparations, or aspirin. 9)Having had treatment with tacrolimus, pitavastatin, rosuvastatin, bosentan, aliskiren, asunaprevir or vaniprevir. 10)Aspartate aminotransferase or, alanine aminotransferase values of 500 IU/L or higher. 11)An estimated glomerular filtration rate of 50 mL/min/1.73 m2 or lower. 12)Presence of an active bacterial infection: septicaemia, meningitis purulenta, peritonitis or bacterial pneumonia. 13)Treatment with other investigational drugs within 12 weeks of study commencement. 14)Others: patients who are judged to be inappropriate for participants of the clinical study for safety reasons by the investigators or the sub-investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method