Unique ID issued by UMIN | UMIN000017585 |
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Receipt number | R000020359 |
Scientific Title | Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease |
Date of disclosure of the study information | 2015/05/15 |
Last modified on | 2018/02/05 13:20:38 |
Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease
KAICA Trial
Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease
KAICA Trial
Japan |
Severe Kawasaki disease
Pediatrics | Child |
Others
YES
The objective of this randomized comparative study is to verify whether immunoglobulin (IVIG) + cyclosporin A (CsA) combination therapy as the primary treatment is superior to the standard IVIG treatment in preventing the development of coronary artery abnormalities (CAAs) in pediatric patients with severe Kawasaki disease (KD).
Safety,Efficacy
Frequency of CAAs during the study period (central review of echocardiography data)
[Efficacy]
1)Frequency of CAA at week 4
2)Frequency of treatment resistance (initial treatment unresponsiveness or relapse during the 12 weeks after treatment initiation.)
3)Z scores for the right coronary artery, and the left main coronary trunk and anterior descending artery.
4)Fever duration
5)Changes in body temperature, frequency of defervescence.
6)Change in serum concentration of C reactive protein (CRP).
7)Genotype frequency of ITPKC and CASP3 SNPs.
8)Additional treatment and follow-up treatment.
[Safety]
1)Frequency of AEs
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
CsA (5 mg/kg/day in 2 divided doses*5days) + IVIG (2 g/kg*1 day] + Aspirin(30 mg/kg/day in 3 divided doses every day)
IVIG 2g/kg*1 day + Aspirin 30 mg/kg/day
4 | months-old | <= |
Not applicable |
Male and Female
1)Pediatric patients with a diagnosis of KD according to the Kawasaki Disease Diagnostic Guideline (the 5th revised edition).
Patients who meet 5 of the 6 main symptoms below are diagnosed as having KD.
2)Severe KD patients with a risk score of 5 points or higher.
The risk score is defined as the sum of all items in the risk-scoring system (5 blood exam data, 2 demographic data of the subjects) developed by Kobayashi et al. Of note, the risk scoring will be performed using a method employed in the previous literature in which the worst values of the blood exam obtained within the acceptable range of time points will be adopted.
3)Age of 4 months or more at the time of signing the informed consent form.
4)Inclusion in the study within 7 days of disease onset. (considering day 1 to be the day when the fever develops.)
5)Informed consent form signed by the patient or a legal guardian.
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.
172
1st name | |
Middle name | |
Last name | Akira Hata |
Chiba University Hospital
Division of Medical Genetics
Inohana 1-8-1, Chuo-ku, Chiba, Chiba 260-8-670
043-222-7171
ahata@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Yasuhisa Fujii |
Chiba University Hospital
Chiba Clinical Research Center
Inohana 1-8-1, Chuo-ku, Chiba, Chiba 260-8-670
043-222-1206
http://www.chiba-crc.jp/kaica_trial-pc/index.html
chibaARO-CRA@ml.chiba-u.jp
Chiba University Hospital
Japan Medical Association
Other
YES
JMA-IIA00174
Japan Medical Association
2015 | Year | 05 | Month | 15 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 01 | Day |
2014 | Year | 05 | Month | 29 | Day |
2016 | Year | 12 | Month | 27 | Day |
2017 | Year | 06 | Month | 05 | Day |
2017 | Year | 06 | Month | 07 | Day |
2017 | Year | 08 | Month | 07 | Day |
2015 | Year | 05 | Month | 15 | Day |
2018 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020359
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