Kawasaki DiseasePhase 3NCT04078568
Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
A Phase 3 study testing IVIG, Aspirin and Prednisolone in people with Kawasaki Disease, run by Children's Hospital of Fudan University at 34 sites in China.
Trial 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) . Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- IVIG, Aspirin and Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,208 participants
- Where
- 34 sitesChina
- Study dates
- 15 Jan 2020to 6 Nov 2025
- Phase
- Phase 3
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, 100020
Bengbu First People's Hopital
Bengbu, Anhui, 233000
The First Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Provincial People's Hospital
Changsha, Hunan, 410002
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610074
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Hangzhou First people's Hospital
Hangzhou, Zhejiang, 310006
Anhui Children's Hospital
Hefei, Anhui, 230022
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, 010017
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Kaifeng Children's Hospital
Kaifeng, Henan, 475000
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Liuzhou Maternity and Children Healthcare Hospital
Liuzhou, Guangxi, 545001
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210008
Qingdao Women and Children's Hospital (Liaoyang West Road)
Qingdao, Shandong, 266011
Qingdao Women and Children's Hospital
Qingdao, Shandong, 266011
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, 200040
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518038
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, 442000
Children's hospital of Soochow University
Suzhou, Jiangsu, 215003
Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xi'an Children's Hospital
Xi'an, Shaanxi, 710003
Xiamen Children's Hospital
Xiamen, Fujian, 361006
Xuzhou Children's Hospital
Xuzhou, Jiangsu, 221006
Henan Children's Hospital
Zhengzhou, Henan, 450018
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial
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) .
Read the detailed description
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.
- Conditions
- Kawasaki Disease
- Being tested
- IVIG, Aspirin, Prednisolone
- Keywords
- Kawasaki disease, prednisolone, coronary artery lesion
- 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.
IVIGDrug
Also called Intravenous Immunoglobulins, Human
IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
AspirinDrug
Also called Acetylsalicylic acid
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.
PrednisoloneDrug
Also called STEROLONE
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.
| Study group | Role | What they receive |
|---|---|---|
| the standard group | Active comparator | 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. Receives: Drug: IVIG; Drug: Aspirin |
| the standard+prednisolone group | Experimental | 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. Receives: Drug: IVIG; Drug: Aspirin; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at one month of illness
Secondary outcomes (17)
Percentage of the need for additional treatment
Axillary temperature (or rectal temperature) will be measured every 6 hours a day during hospitalization. Participants who have recurrent or persistent fever (axillary temperature ≥37.5°C or rectal temperature ≥38°C) after 36 hours of completion of initial IVIG infusion will be given additional treatment.
Measured: from admission to discharge (about 2 weeks of illness)
Duration of fever (hours) after initiation of initial IVIG infusion
Axillary temperature (or rectal temperature) will be measured every 6 hours a day during hospitalization. Participants with an axillary temperature <37.5℃ (or rectal temperature <38℃) for more than 24 hours are considered afebrile. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal.
Measured: 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
This is a repeated measurement. The internal diameter of LMCA will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）.
Measured: from admission to 12 months of illness
Changes in z scores of LAD throughout the study period
This is a repeated measurement. The internal diameter of LAD will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）.
Measured: from admission to 12 months of illness
Changes in z scores of LCX throughout the study period
This is a repeated measurement. The internal diameter of LCX will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）.
Measured: from admission to 12 months of illness
Changes in z scores of the proximal segment of RCA throughout the study period
This is a repeated measurement. The internal diameter of the proximal segment of RCA will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）.
Measured: from admission to 12 months of illness
Changes in z scores of the middle segment of RCA throughout the study period
This is a repeated measurement. The internal diameter of the middle segment of RCA will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）.
Measured: from admission to 12 months of illness
Change in serum C-reactive protein (CRP) concentration
CRP level is measured before initial IVIG infusion and 72 hours after completion of initial IVIG infusion.
Measured: from admission to 72 hours after completion of initial IVIG infusion
Number of patients with serious adverse events
This is a composite outcome, including death, hypertension, severe infection, allergic reactions, heart failure, thrombosis, etc.
Measured: from admission to 3 months of illness
Occurrence of medium-to-giant coronary artery aneurysms (CAAs)
Exploratory Outcome. This is a repeatedly measured binary variable. CAL classification is based on the maximum z score according to the 2017 American Heart Association guideline. Medium CAA is defined as a maximum Z score ≥5 to <10, and all internal diameters <8 mm; large or giant CAA is defined as a maximum Z score ≥10, or any internal diameter ≥8 mm. Data were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Occurrence of large/giant CAAs
Exploratory Outcome. This is a repeatedly measured binary variable. CAL classification is based on the maximum z score according to the 2017 American Heart Association guideline. Medium CAA is defined as a maximum Z score ≥5 to <10, and all internal diameters <8 mm; large or giant CAA is defined as a maximum Z score ≥10, or any internal diameter ≥8 mm. Data were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Occurrence of CAL progression within 3 months of illness onset
Exploratory outcome. CAL progression is defined as an increment in the Z score ≥1 from admission in any coronary artery (LMCA, LAD, LCX, proximal and middle segments of RCA) at any given time point within 3 months of illness onset. The outcome was assessed in all participants and those with CAL at baseline.
Measured: from admission to 3 months of illness onset
Changes in absolute diameter of LMCA throughout the study period
Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of LMCA were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Changes in absolute diameter of LAD throughout the study period
Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of LAD were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Changes in absolute diameter of LCX throughout the study period
Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of LCX were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Changes in absolute diameter of the proximal segment of RCA throughout the study period
Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of the proximal segment of RCA were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Changes in absolute diameter of the middle segment of RCA throughout the study period
Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of the middle segment of RCA were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively.
Measured: from admission to 12 months of illness onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Jan 2020
- Primary completion30 Dec 2024
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Children's Hospital of Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Province Children's Hospital, First People's Hospital of Hangzhou, Shengjing Hospital, The First Hospital of Jilin University, Chengdu Women's and Children's Central Hospital, Children's Hospital of Chongqing Medical University, Inner Mongolia People's Hospital, Sichuan Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Third Affiliated Hospital of Zhengzhou University, Children's Hospital of Soochow University, Yuying Children's Hospital of Wenzhou Medical University, Beijing Children's Hospital, Qilu Hospital of Shandong University
- Responsible party
- Sponsor
- Investigators
- Fang Liu, MD., Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078568
- Sponsor's protocol ID
- KD-3-01
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2018
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin S, He Y, He L, Liu Y, Wang F, Xiong Z, Lin Y, Ye L, Chu C, Wang F, Zhao L, Cao Y, Zheng Y, Huang Q, Wang J, Liang X, Zhao Q, Sun S, Dou Y, He W, Huang X, Sun J, Huang X, Li Y, Liao Y, Lv H, Pan S, Zhu H, An X, He X, Zhao C, Liu X, Hu Y, Piao J, Qin L, Dong X, Peng Q, Wang C, Lin S, Huang P, Wu R, Peng H, Li Z, Wang D, Liu X, Yan W, Liu F, Huang G; Chinese Kawasaki Disease Collaboration Network. Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease. N Engl J Med. 2026 Apr 16;394(15):1480-1490. doi: 10.1056/NEJMoa2511478.
PubMed 41985133Lin 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.
PubMed 34895290
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04078568
- Acronym / sponsor ID
- KD-3-01
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki disease, prednisolone, coronary artery lesion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,208 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Jiangxi Province Children's Hospital, First People's Hospital of Hangzhou, Shengjing Hospital, The First Hospital of Jilin University, Chengdu Women's and Children's Central Hospital, Children's Hospital of Chongqing Medical University, Inner Mongolia People's Hospital, Sichuan Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Third Affiliated Hospital of Zhengzhou University, Children's Hospital of Soochow University, Yuying Children's Hospital of Wenzhou Medical University, Beijing Children's Hospital, Qilu Hospital of Shandong University
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
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) .
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the standard group | Active comparator | Drug: IVIG, Drug: Aspirin1. 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 | Experimental | Drug: IVIG, Drug: Aspirin, Drug: Prednisolone1. 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. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| IVIGAlso: Intravenous Immunoglobulins, HumanIVIG at a single dose of 2 g/kg, with the maximum dose of 60g | Drug | the standard group, the standard+prednisolone group |
| AspirinAlso: Acetylsalicylic acidAspirin 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. | Drug | the standard group, the standard+prednisolone group |
| PrednisoloneAlso: STEROLONEIntravenous 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. | Drug | the standard+prednisolone group |
Primary outcome
Percentage of coronary artery lesions(CAL) at one month of illness
Time frame: 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.
17 secondary outcomes
Percentage of the need for additional treatment
Time frame: from admission to discharge (about 2 weeks of illness)
Duration of fever (hours) after initiation of initial IVIG infusion
Time frame: 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
Time frame: from admission to 12 months of illness
Changes in z scores of LAD throughout the study period
Time frame: from admission to 12 months of illness
Changes in z scores of LCX throughout the study period
Time frame: from admission to 12 months of illness
Changes in z scores of the proximal segment of RCA throughout the study period
Time frame: from admission to 12 months of illness
Changes in z scores of the middle segment of RCA throughout the study period
Time frame: from admission to 12 months of illness
Change in serum C-reactive protein (CRP) concentration
Time frame: from admission to 72 hours after completion of initial IVIG infusion
Number of patients with serious adverse events
Time frame: from admission to 3 months of illness
Occurrence of medium-to-giant coronary artery aneurysms (CAAs)
Time frame: from admission to 12 months of illness onset
Occurrence of large/giant CAAs
Time frame: from admission to 12 months of illness onset
Occurrence of CAL progression within 3 months of illness onset
Time frame: from admission to 3 months of illness onset
Changes in absolute diameter of LMCA throughout the study period
Time frame: from admission to 12 months of illness onset
Changes in absolute diameter of LAD throughout the study period
Time frame: from admission to 12 months of illness onset
Changes in absolute diameter of LCX throughout the study period
Time frame: from admission to 12 months of illness onset
Changes in absolute diameter of the proximal segment of RCA throughout the study period
Time frame: from admission to 12 months of illness onset
Changes in absolute diameter of the middle segment of RCA throughout the study period
Time frame: from admission to 12 months of illness onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 41985133Lin S, He Y, He L, Liu Y, Wang F, Xiong Z, Lin Y, Ye L, Chu C, Wang F, Zhao L, Cao Y, Zheng Y, Huang Q, Wang J, Liang X, Zhao Q, Sun S, Dou Y, He W, Huang X, Sun J, Huang X, Li Y, Liao Y, Lv H, Pan S, Zhu H, An X, He X, Zhao C, Liu X, Hu Y, Piao J, Qin L, Dong X, Peng Q, Wang C, Lin S, Huang P, Wu R, Peng H, Li Z, Wang D, Liu X, Yan W, Liu F, Huang G; Chinese Kawasaki Disease Collaboration Network. Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease. N Engl J Med. 2026 Apr 16;394(15):1480-1490. doi: 10.1056/NEJMoa2511478.
- Derived from this study: PubMed 34895290Lin 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.
- Individual participant dataSharing planned: No
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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.
Fang Liu, MD. study director
Children's Hospital of Fudan University
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVIG, Aspirin and Prednisolone in people with Kawasaki Disease, run by Children's Hospital of Fudan University at 34 sites in China.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of coronary artery lesions(CAL) at one month of illness (time frame: at one month of illness). 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 NCT04078568, which also lists 2 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 16 Apr 2026.