A Study for Finding Optimal Indication for Cicrosporine A in Patients with Kawasaki Disease

JRCT ID: jRCTs031230101

Registered date:29/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Kawasaki Disease
• Date of first enrollment: 29/05/2023
• Target sample size: 320
• Study type: Interventional

Intervention(s)

1) Cicrosporin A CsA at 2.5 mg/kg/day in two separate oral doses, morning and evening, in total of 10 doses is administered as primary treatment. The interval between CsA doses should be at least 6 hours.
2) IVIG is given as an intravenous infusion at a dose of 0.01 mL/kg/min during the initial 1 hour, and after that, <0.03 mL/kg/min, over 10 hours.
3) As primary treatment, aspirin ASA 30-50 mg/kg/day in three separate doses is used. After confirming defervescence, the dose is reduced to 5 mg/kg/day once daily according to the study institution's policy.

Outcome(s)

Primary Outcome

The relationship between genotypes of ITPKC SNVs (rs28493229; G/C) and the presence or absence of coronary artery lesions

In addition, multivariate logistic analysis will be used with the following items as adjustment factors.
hematocrit
pretreatment coronary Z-score (right coronary artery, left main coronary artery, left anterior descending branch, Left circumflex branch)

Secondary Outcome

The relationship between the presence or absence of coronary artery lesions with a Z-score >= 2.5 or >= 3.0 within the study period (4 weeks after enrollment) and following items

1) genotypes of ITPKC and CASP3 SNVs (rs28493229; G/C and rs113420705; G/A)
2) hematological test values (including hematocrit)
3) biochemical test (including total bilirubin)
4) pretreatment blood cytokine/chemokine profile
5) Myl9

Key inclusion & exclusion criteria

• Age minimum: >= 4month old
• Age maximum: < 15age old
• Gender: Both

Include criteria

1) Pediatric patients with a diagnosis of KD according to the Kawasaki Disease Diagnostic Criteria (the 6th revised edition)23) (the 6th revised edition prepared by Kawasaki Disease Research Committee, the Ministry of Health, Labour and Welfare, 2020).
2)Age of between 4 months and 15 years at the time of signing the informed consent form
3) Inclusion in the study within 9 days of disease onset (considering day 1 to be the day when the fever develops)
4)Informed consent form signed by a legal guardian

Exclude criteria

1)Defervescence prior to enrollment
2)Suspicion that the symptoms may correspond to a disease other than KD (haemolytic streptococcal infection, EB virus infection, adenovirus infection Yersinia infection, measles, or Stevens-Johnson syndrome)
3)Initiation of IVIG treatment later than 9 days after disease onset
4)Having had treatment with tacrolimus (except external preparations), pitavastatin, rosuvastatin, bosentan, or aliskiren
5)History of hypersensitivity to CsA preparations, immunoglobulin preparations, or aspirin
6)Presence of an active bacterial infection: septicaemia, purulent meningitis, peritonitis or bacterial pneumonia
7)Treatment with other investigational drugs within 12 weeks of study commencement
8)Treatment with BCG vaccine or other live vaccine within 4 weeks of study commencement, or treatment with inactivated vaccine within 2 weeks of study commencement
9)Others: patients who are judged to be inappropriate for participants of the clinical study for safety reasons by the investigators or the sub-investigators

Related Information

• Primary Sponsor: Hamada Hiromichi
• Source(s) of Monetary Support: CREATION-Fund of CUH,Japan Agency for Medical Research and Development,Clinical Research Initiation-Fund (of Chiba University Hospital)