UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017585 |
|---|---|
| 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 |
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Basic information
Public title
Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease
Acronym
KAICA Trial
Scientific Title
Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease
Scientific Title:Acronym
KAICA Trial
Region
| Japan |
Condition
Condition
Severe Kawasaki disease
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
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).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of CAAs during the study period (central review of echocardiography data)
Key secondary outcomes
[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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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)
Interventions/Control_2
IVIG 2g/kg*1 day + Aspirin 30 mg/kg/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Hata |
Organization
Chiba University Hospital
Division name
Division of Medical Genetics
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba, Chiba 260-8-670
TEL
043-222-7171
ahata@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Fujii |
Organization
Chiba University Hospital
Division name
Chiba Clinical Research Center
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba, Chiba 260-8-670
TEL
043-222-1206
Homepage URL
http://www.chiba-crc.jp/kaica_trial-pc/index.html
chibaARO-CRA@ml.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00174
Org. issuing International ID_1
Japan Medical Association
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 05 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 07 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2018 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020359
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
