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NCT Number: NCT04078568

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

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) .

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bengbu First People's Hopital, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

IVIG

Drug

IVIG at a single dose of 2 g/kg, with the maximum dose of 60g

Other names: Intravenous Immunoglobulins, Human

Aspirin

Drug

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.

Other names: Acetylsalicylic acid

Prednisolone

Drug

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 names: STEROLONE

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of the need for additional treatment

    Time frame: from admission to discharge (about 2 weeks of illness)

    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.

  2. 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)

    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.

  3. Changes in z scores of LMCA throughout the study period

    Time frame: from admission to 12 months of illness

    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).）.

  4. Changes in z scores of LAD throughout the study period

    Time frame: from admission to 12 months of illness

    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).）.

  5. Changes in z scores of LCX throughout the study period

    Time frame: from admission to 12 months of illness

    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).）.

  6. Changes in z scores of the proximal segment of RCA throughout the study period

    Time frame: from admission to 12 months of illness

    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).）.

  7. Changes in z scores of the middle segment of RCA throughout the study period

    Time frame: from admission to 12 months of illness

    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).）.

  8. Change in serum C-reactive protein (CRP) concentration

    Time frame: from admission to 72 hours after completion of initial IVIG infusion

    CRP level is measured before initial IVIG infusion and 72 hours after completion of initial IVIG infusion.

  9. Number of patients with serious adverse events

    Time frame: from admission to 3 months of illness

    This is a composite outcome, including death, hypertension, severe infection, allergic reactions, heart failure, thrombosis, etc.

  10. Occurrence of medium-to-giant coronary artery aneurysms (CAAs)

    Time frame: from admission to 12 months of illness onset

    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.

  11. Occurrence of large/giant CAAs

    Time frame: from admission to 12 months of illness onset

    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.

  12. Occurrence of CAL progression within 3 months of illness onset

    Time frame: from admission to 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.

  13. Changes in absolute diameter of LMCA throughout the study period

    Time frame: from admission to 12 months of illness onset

    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.

  14. Changes in absolute diameter of LAD throughout the study period

    Time frame: from admission to 12 months of illness onset

    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.

  15. Changes in absolute diameter of LCX throughout the study period

    Time frame: from admission to 12 months of illness onset

    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.

  16. Changes in absolute diameter of the proximal segment of RCA throughout the study period

    Time frame: from admission to 12 months of illness onset

    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.

  17. Changes in absolute diameter of the middle segment of RCA throughout the study period

    Time frame: from admission to 12 months of illness onset

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Beijing Children's Hospital
  • Chengdu Women's and Children's Central Hospital
  • Children's Hospital of Chongqing Medical 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

Registry information

Official study title

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Sep 6, 2019
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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