Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
1 other identifier
interventional
3,208
1 country
34
Brief Summary
This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2020
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2025
CompletedApril 16, 2026
April 1, 2026
5 years
August 16, 2018
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of coronary artery lesions(CAL) at one month of illness
Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. The measurement of each patient included the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated（Journal of the American Society of Echocardiography, 2011, 24(1).）. CAL is defined as z≥2of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.
at one month of illness
Secondary Outcomes (17)
Percentage of the need for additional treatment
from admission to discharge (about 2 weeks of illness)
Duration of fever (hours) after initiation of initial IVIG infusion
from initiation of initial IVIG infusion to the first record of being afebrile(defined as an axillary temperature <37.5 for more than 24 hours)
Changes in z scores of LMCA throughout the study period
from admission to 12 months of illness
Changes in z scores of LAD throughout the study period
from admission to 12 months of illness
Changes in z scores of LCX throughout the study period
from admission to 12 months of illness
- +12 more secondary outcomes
Study Arms (2)
the standard group
ACTIVE COMPARATOR1. 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.
the standard+prednisolone group
EXPERIMENTAL1. 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.
Interventions
IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
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.
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.
Eligibility Criteria
You may qualify if:
- Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017
- 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
You may not qualify if:
- Z score of any coronary artery before initial treatment ≥10
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Fudan Universitylead
- Jiangxi Province Children's Hospitalcollaborator
- Shengjing Hospitalcollaborator
- First People's Hospital of Hangzhoucollaborator
- The First Hospital of Jilin Universitycollaborator
- Chengdu Women's and Children's Central Hospitalcollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- Inner Mongolia People's Hospitalcollaborator
- Sichuan Provincial People's Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Third Affiliated Hospital of Zhengzhou Universitycollaborator
- Children's Hospital of Soochow Universitycollaborator
- Yuying Children's Hospital of Wenzhou Medical Universitycollaborator
- Beijing Children's Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
Study Sites (34)
Bengbu First People's Hopital
Bengbu, Anhui, 233000, China
Anhui Children's Hospital
Hefei, Anhui, 230022, China
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, 100020, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, China
Xiamen Children's Hospital
Xiamen, Fujian, 361006, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518038, China
Liuzhou Maternity and Children Healthcare Hospital
Liuchow, Guangxi, 545001, China
Kaifeng Children's Hospital
Kaifeng, Henan, 475000, China
Henan Children's Hospital
Zhengzhou, Henan, 450018, China
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, 442000, China
Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410002, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, 010017, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210008, China
Children's hospital of Soochow University
Suzhou, Jiangsu, 215003, China
Xuzhou Children's Hospital
Xuzhou, Jiangsu, 221006, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Xi'an Children's Hospital
Xi'an, Shaanxi, 710003, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Qingdao Women and Children's Hospital (Liaoyang West Road)
Qingdao, Shandong, 266011, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, 266011, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, 200040, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610074, China
Hangzhou First people's Hospital
Hangzhou, Zhejiang, 310006, China
Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
Related Publications (1)
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.
PMID: 34895290DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fang Liu, MD.
Children's Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and physicians will not be masked to the assignment. Pediatric cardiologists who assess coronary artery lesions (CAL) by echocardiography will be masked to the allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2018
First Posted
September 6, 2019
Study Start
January 15, 2020
Primary Completion
December 30, 2024
Study Completion
November 6, 2025
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share