Kawasaki DiseaseNCT02951234
A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease
A study testing IVIG only and IVIG and Aspirin in people with Kawasaki Disease, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.
Trial summary
Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in… Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- IVIG only and IVIG and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 5 sitesTaiwan
- Study dates
- Sep 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Male or female, under the age of 7 years old.
- 2. Fulfilled the AHA criteria for KD as explained below:
- Fever (more than 38.0℃ ear temperature) > or = 5 days, as well as 4 of the 5 following symptoms
- Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips)
- Bilateral non-purulent conjunctivitis
- Dysmorphous skin rashes
Show all 10Show fewer
- Indurative edematous change over the hands and feet, or desquamation over the fingertips or toes
- Cervical lymphadenopathy (one or more nodule at least 1.5 cm in diameter)
- 3. An informed consent form (ICF, appendix B) signed by the patient or a legal guardian.
- -
Who cannot join
- Had symptoms that did not completely match the KD criteria.
- Had an acute fever for < 5 days and >10 days
- IVIG treatment at another hospital before being referred to the study center.
- Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study;
- The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.).
- Previous KD diagnosis.
Show all 13Show fewer
- Inability to take aspirin (such as history of hypersensitivity to aspirin, G6PD deficiency, recent herpes zoster infection or vaccination, etc.)
- Afebrile prior to enrollment
- CAL prior to enrollment
- Severe concomitant medical disorders (e.g., immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.)
- Suspected to have an infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza
- Judged by the researcher to be unsuitable for this trial.
- -
Trial locations and contacts
5 sites in 1 country.
Ho-Chang Kuo, MD, PhD contact
Ying-Hsien Huang, MD, PhD contact
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Ken-Pen Weng, MD, +886-975581955, kenpenweng@yahoo.com.tw
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Ho-Chang Kuo, MD, PhD, erickuo48@yahoo.com.tw
Ying-Hsien Huang, MD, PhD, yhhuang123@yahoo.com.tw
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Ming-Chih Lin, MD, +886-917620556, mingclin@gmail.com
- Recruiting
Tungs' Taichung Metroharbor Hospital
Taichung, 433
Chung-Chih Kao, MD, +886-935279276, cckao2cv@yahoo.com
- Recruiting
Linkou Chang Gung Memorial Hospital
Taipei
Chih-Jung Chen, MD, chinjung@adm.cgmh.org.tw
About this study
Official title: Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan
Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.
Read the detailed description
Background: Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. High-dose aspirin is often administered, but the duration of such treatment varies. Many centers reduce the aspirin dose once the patient is afebrile, even before treating said patient with IVIG. However, a randomized controlled trial regarding high-dose aspirin in the acute stage of KD has not previously been carried out.
Methods/design: This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks. Patients meeting the eligibility criteria are randomly assigned (1:1) to a test group (that receives only IVIG) or a standard group (that receives IVIG plus high-dose aspirin). This clinical trial is conducted at seven medical centers in Taiwan.
Discussion: Since high-dose aspirin has significant anti-inflammatory and anti-platelet functions, it does not appear to lower the frequency of disease outcomes. Furthermore, it can decrease hemoglobin levels. Therefore, the investigators have initiated this randomized controlled trial to determine whether high-dose aspirin is necessary in the acute stage of KD.
- Conditions
- Kawasaki Disease
- Being tested
- IVIG only, IVIG and Aspirin
- Keywords
- coronary artery lesions, intravenous immunoglobulin, Kawasaki disease, randomized clinical trial, aspirin
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG onlyOther
All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin.
IVIG and AspirinOther
All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside.
| Study group | Role | What they receive |
|---|---|---|
| IVIG only | Experimental | All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks. Receives: Other: IVIG only |
| IVIG and Aspirin | Active comparator | All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks. Receives: Other: IVIG and Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary artery lesions
Measured: 8 weeks
Secondary outcomes (1)
IVIG resistance
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Chang Kuo, MD, PhD, Principal investigator, Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951234
- Sponsor's protocol ID
- IVIG And Aspirin in KD
- Status last verified
- Mar 2018
- First submitted
- 28 Oct 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kuo HC, Lin MC, Kao CC, Weng KP, Ding Y, Han Z, Chen CJ, Jan SL, Chien KJ, Ko CH, Lin CY, Lei WT, Guo MM, Yang KD, Sylvester KG, Whitin JC, Tian L, Chubb H, Ceresnak SR, McElhinney D, Cohen HJ, Ling XB. Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253063. doi: 10.1001/jamanetworkopen.2025.3063.
PubMed 40178858Kuo HC, Lin MC, Kao CC, Weng KP, Ding Y, Chen CJ, Jan SL, Chien KJ, Ko CH, Lin CY, Lei WT, Chang LS, Guo MM, Yang KD, Sylvester KG, Han Z, Whitin JC, Tian L, Chubb H, Ceresnak SR, McElhinney D, Cohen HJ, Ling XB. EFFICACY OF INTRAVENOUS IMMUNOGLOBULIN ALONE ON CORONARY ARTERY LESION REDUCTION IN KAWASAKI DISEASE. medRxiv [Preprint]. 2024 Jul 12:2024.07.11.24310310. doi: 10.1101/2024.07.11.24310310.
PubMed 39040184Kuo HC, Guo MM, Lo MH, Hsieh KS, Huang YH. Effectiveness of intravenous immunoglobulin alone and intravenous immunoglobulin combined with high-dose aspirin in the acute stage of Kawasaki disease: study protocol for a randomized controlled trial. BMC Pediatr. 2018 Jun 22;18(1):200. doi: 10.1186/s12887-018-1180-1.
PubMed 29933749
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan
- ClinicalTrials.gov ID
- NCT02951234
- Acronym / sponsor ID
- IVIG And Aspirin in KD
- Conditions
- Kawasaki Disease
- Keywords
- coronary artery lesions, intravenous immunoglobulin, Kawasaki disease, randomized clinical trial, aspirin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.
Detailed description
Background: Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. High-dose aspirin is often administered, but the duration of such treatment varies. Many centers reduce the aspirin dose once the patient is afebrile, even before treating said patient with IVIG. However, a randomized controlled trial regarding high-dose aspirin in the acute stage of KD has not previously been carried out.
Methods/design: This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks. Patients meeting the eligibility criteria are randomly assigned (1:1) to a test group (that receives only IVIG) or a standard group (that receives IVIG plus high-dose aspirin). This clinical trial is conducted at seven medical centers in Taiwan.
Discussion: Since high-dose aspirin has significant anti-inflammatory and anti-platelet functions, it does not appear to lower the frequency of disease outcomes. Furthermore, it can decrease hemoglobin levels. Therefore, the investigators have initiated this randomized controlled trial to determine whether high-dose aspirin is necessary in the acute stage of KD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG only | Experimental | Other: IVIG onlyAll patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks. |
| IVIG and Aspirin | Active comparator | Other: IVIG and AspirinAll patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 1. Male or female, under the age of 7 years old.
- Fever (more than 38.0℃ ear temperature) > or = 5 days, as well as 4 of the 5 following symptoms
- Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips)
- Bilateral non-purulent conjunctivitis
- Dysmorphous skin rashes
Key exclusion criteria (13 listed)
- Had symptoms that did not completely match the KD criteria.
- Had an acute fever for < 5 days and >10 days
- IVIG treatment at another hospital before being referred to the study center.
- Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study;
- The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG onlyAll patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. | Other | IVIG only |
| IVIG and AspirinAll patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. | Other | IVIG and Aspirin |
Primary outcome
coronary artery lesions
Time frame: 8 weeks
1 secondary outcome
IVIG resistance
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 40178858Kuo HC, Lin MC, Kao CC, Weng KP, Ding Y, Han Z, Chen CJ, Jan SL, Chien KJ, Ko CH, Lin CY, Lei WT, Guo MM, Yang KD, Sylvester KG, Whitin JC, Tian L, Chubb H, Ceresnak SR, McElhinney D, Cohen HJ, Ling XB. Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253063. doi: 10.1001/jamanetworkopen.2025.3063.
- Derived from this study: PubMed 39040184Kuo HC, Lin MC, Kao CC, Weng KP, Ding Y, Chen CJ, Jan SL, Chien KJ, Ko CH, Lin CY, Lei WT, Chang LS, Guo MM, Yang KD, Sylvester KG, Han Z, Whitin JC, Tian L, Chubb H, Ceresnak SR, McElhinney D, Cohen HJ, Ling XB. EFFICACY OF INTRAVENOUS IMMUNOGLOBULIN ALONE ON CORONARY ARTERY LESION REDUCTION IN KAWASAKI DISEASE. medRxiv [Preprint]. 2024 Jul 12:2024.07.11.24310310. doi: 10.1101/2024.07.11.24310310.
- Derived from this study: PubMed 29933749Kuo HC, Guo MM, Lo MH, Hsieh KS, Huang YH. Effectiveness of intravenous immunoglobulin alone and intravenous immunoglobulin combined with high-dose aspirin in the acute stage of Kawasaki disease: study protocol for a randomized controlled trial. BMC Pediatr. 2018 Jun 22;18(1):200. doi: 10.1186/s12887-018-1180-1.
- Individual participant dataSharing planned: Undecided
Related trials for Kawasaki Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2/3
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Kawasaki Disease
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingPhase 4
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Kawasaki Disease, Coronary Artery Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Chang Kuo, MD, PhD contact
Ying-Hsien Huang, MD, PhD contact
Ho-Chang Kuo, MD, PhD principal investigator
Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVIG only and IVIG and Aspirin in people with Kawasaki Disease, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Chang Kuo, MD, PhD (erickuo48@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary artery lesions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951234, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.