Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
NCT ID: NCT04078568
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
3208 participants
INTERVENTIONAL
2020-01-15
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
the standard group
1. IVIG 2g/kg once, given within 12 to 24 hours;
2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
IVIG
IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
Aspirin
Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
the standard+prednisolone group
1. IVIG 2g/kg once, given within 12 to 24 hours;
2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
3. Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days . If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.
IVIG
IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
Aspirin
Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Prednisolone
Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days. If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IVIG
IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
Aspirin
Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Prednisolone
Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days. If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
* Not treated with IVIG yet
* Age ≥1 month
Exclusion Criteria
* Receiving steroids or other immunosuppressive agents in the previous 30 days
* With a previous history of KD
* Afebrile before enrolment
* With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza
* With serious immune diseases such as immunodeficiency or chromosomal abnormalities
1 Month
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangxi Province Children's Hospital
OTHER
First People's Hospital of Hangzhou
OTHER
Shengjing Hospital
OTHER
The First Hospital of Jilin University
OTHER
Chengdu Women's and Children's Central Hospital
OTHER
Children's Hospital of Chongqing Medical University
OTHER
Inner Mongolia People's Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Third Affiliated Hospital of Zhengzhou University
OTHER
Children's Hospital of Soochow University
OTHER
Yuying Children's Hospital of Wenzhou Medical University
OTHER
Beijing Children's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Children's Hospital of Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fang Liu, MD.
Role: STUDY_DIRECTOR
Children's Hospital of Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bengbu First People's Hopital
Bengbu, Anhui, China
Anhui Children's Hospital
Hefei, Anhui, China
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Xiamen Children's Hospital
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Liuzhou Maternity and Children Healthcare Hospital
Liuchow, Guangxi, China
Kaifeng Children's Hospital
Kaifeng, Henan, China
Henan Children's Hospital
Zhengzhou, Henan, China
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, China
Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Children's hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Children's Hospital
Xuzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Xi'an Children's Hospital
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Qingdao Women and Children's Hospital (Liaoyang West Road)
Qingdao, Shandong, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Hangzhou First people's Hospital
Hangzhou, Zhejiang, China
Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lin SY, He L, Xie LP, Wang Y, Lin YX, Cao YY, Yan WL, Liu F, Huang GY. Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial. Trials. 2021 Dec 11;22(1):898. doi: 10.1186/s13063-021-05807-3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KD-3-01
Identifier Type: -
Identifier Source: org_study_id