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

Fudan University

Status and phase: Active, not recruiting; Phase 3

Conditions: Kawasaki Disease

Treatments: Drug: Aspirin; Drug: Prednisolone; Drug: IVIG

Study type: Interventional

Funder types: Other

Identifiers

NCT04078568

KD-3-01

Details and patient eligibility

About

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) .

Full 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.

Enrollment: 3,208 patients

Sex: All

Ages: 1+ month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,208 participants in 2 patient groups

the standard group

Active Comparator group

Description:

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.

Treatment:

Drug: IVIG

Drug: Aspirin

the standard+prednisolone group

Experimental group

Description:

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.

Treatment:

Drug: Prednisolone

Drug: IVIG

Drug: Aspirin