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An Explorative Study for Finding Optimal Indication Criteria for Immunomodulatory Therapy in Patients with Kawasaki Disease (FORKiDs trial)

A Study for Finding Optimal Indication for Cicrosporine A in Patients with Kawasaki Disease (FORKiDs trial)

Hamada Hiromichi

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba

hamada.hiromichi@chiba-u.jp

Uchiyama Shiori

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba

+81-43-222-7171

sor.ucym@chiba-u.jp

Recruiting

July. 01, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Pediatric patients who meet the revised Diagnostic Guidelines for Kawasaki Disease version 6
2) Pediatric patients aged 4 months or older and younger than 15 years at the time of informed consent
3) Pediatric patients for whom diagnosis was made before Disease Day 9 (The day on which fever developed is defined as Disease Day 1)
4) Pediatric patients whose legal representative provided the consent in writing

1) Pediatric patients who achieved defervescence before registration
2) Pediatric patients whose main disease condition is likely to be hemolytic streptococcal infection, EB virus infection, adenovirus infection, Yersinia infection, measles, or Stevens-Johnson syndrome, which are diseases similar to Kawasaki disease
3) Pediatric patients who started to receive treatment on or after Disease Day 9
4) Pediatric patients who are receiving tacrolimus (excluding topical preparation), pitavastatin, rosuvastatin, bosentan, aliskiren, grazoprevir, or pemafibrate
5) Pediatric patients who had experienced hypersensitivity to ciclosporin preparation, immunoglobulin preparation, or aspirin in the past
6) Pediatric patients whose condition is complicated by active bacterial infections including sepsis, purulent meningitis, peritonitis, and bacterial pneumonia
7) Pediatric patients who received administration of another study medication within 12 weeks before the start of study medication administration
8) Pediatric patients who were vaccinated with live vaccine/BCG within 4 weeks before the start of study medication administration or inactivated vaccine within 2 weeks before the start of study medication administration
9) Other pediatric patients who were judged to be ineligible for safe implementation of this study by the investigators or the sub-investigators.

Both

Kawasaki Disease

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.

Kawasaki disease, Children, Vasculitis, Coronary artery disease

D009080

D27

The presence or absence of CAA through week 4 after enrollment
CAA is defined as Z score >= 2.5.

Efficacy secondary endpoints
1) The presence or absence of CAA through week 4 after enrollment
CAA is defined as Z score >= 3.0
2) The maximum Z score (continuous variable) within 4 weeks after registration
3) Incidence of patients with CAA at each assessment time point
CAA is defined separately using two thresholds:
Z score >= 2.5, Z score >= 3.0
4) Maximum Z score (continuous value) at each assessment point
5) Incidence of CAA in patients with the following factors a.-d. within 4 weeks after registration
CAA is defined separately using two thresholds:
Z score >= 2.5, Z score >= 3.0
6) Association between Z score (continuous variable) up to 4 weeks after registration, based on the following factors a.-d.

a. Hematocrit
b. Total bilirubin
c. Blood cytokine/chemokine levels
d. Blood myl9 levels

Safety secondary endpoints
Frequency of occurrence of adverse events

+81-43-226-2616

May. 15, 2026

No

Taiwan