Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial
Sponsor: Beijing Children's Hospital
Listed as NCT04078568, this observational or N/A phase trial focuses on Kawasaki Disease and remains completed. Sponsored by Beijing Children's Hospital, it has been updated 21 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months，and 12 months after onset of KD to assess the coronary artery lesions.
This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months，and 12 months after onset of KD to assess the coronary artery lesions.
Status Flow
Change History
21 versions recorded-
Apr 17, 2026 — Present [daily]
Completed
Status: Active Not Recruiting → Completed · Phase: PHASE3 → None
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Jan 2026 — Apr 2026 [monthly]
Active Not Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Active Not Recruiting PHASE3
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Sep 2025 — Dec 2025 [monthly]
Active Not Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE3
▶ Show 16 earlier versions
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Feb 2025 — Aug 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Dec 2024 — Feb 2025 [monthly]
Recruiting PHASE3
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Nov 2024 — Dec 2024 [monthly]
Recruiting PHASE3
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Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE3
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jan 2024 — Jul 2024 [monthly]
Recruiting PHASE3
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Oct 2023 — Jan 2024 [monthly]
Recruiting PHASE3
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Sep 2023 — Oct 2023 [monthly]
Recruiting PHASE3
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Feb 2023 — Sep 2023 [monthly]
Recruiting PHASE3
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Feb 2022 — Feb 2023 [monthly]
Recruiting PHASE3
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Apr 2021 — Feb 2022 [monthly]
Recruiting PHASE3
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Jan 2021 — Apr 2021 [monthly]
Recruiting PHASE3
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Mar 2020 — Jan 2021 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting · Phase: PHASE4 → PHASE3
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Jan 2020 — Mar 2020 [monthly]
Not Yet Recruiting PHASE4
Phase: PHASE3 → PHASE4
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Oct 2019 — Jan 2020 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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) .
Contact Information
- Beijing Children's Hospital
- Chengdu Women's and Children's Central Hospital
- Children's Hospital of Chongqing Medical University
- Children's Hospital of Fudan University
- Children's Hospital of Soochow University
- First People's Hospital of Hangzhou
- Inner Mongolia People's Hospital
- Jiangxi Province Children's Hospital
- Qilu Hospital of Shandong University
- Shengjing Hospital
- Sichuan Provincial People's Hospital
- The First Hospital of Jilin University
- Third Affiliated Hospital of Zhengzhou University
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Yuying Children's Hospital of Wenzhou Medical University
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Beijing, China , Bengbu, China , Changchun, China , Changsha, China , Chengdu, China , Chengdu, China , Chongqing, China , Guangzhou, China , Guangzhou, China , Hangzhou, China and 24 more locations