UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017585
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email chibaARO-CRA@ml.chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.