Different Doses of IVIG for Kawasaki Disease

Fudan University

Status and phase: Completed; Phase 3

Conditions: Kawasaki Disease

Treatments: Drug: IVIG (1g/kg,once); Drug: IVIG (2g/kg.once); Drug: IVIG (1g/kg,twice)

Study type: Interventional

Funder types: Other

Identifiers

NCT02439996

KD(2015-2016)

Details and patient eligibility

About

The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.

Full description

Kawasaki disease is an acute febrile illness recognized most often in young children. Coronary abnormality is the most serious complication preventable with intravenous immunoglobulin (IVIG) administration. Various treatment regimens of IVIG have been reported.The optimal administrative doses of IVIG deserves more observations.We will conduct a multicenter, randomized, prospective trial to determine the effect of different doses of IVIG (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease. The KD children will be randomly assigned to three groups and were given different IVIG regimen (1g/kg once, 1g/kg twice, 2g/kg once)as initial treatment. Patient age, gender, white blood cell count, hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), red blood cell specific volume (HCT) , serum albumin, the fever days,and the cost of hospital stay will be analyzed among the three groups. The primary outcome is the duration of fever subsided and the incidence of coronary artery lesions .

Enrollment: 404 patients

Sex: All

Ages: 1 month to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.
• the patients aged from 1 months to 12 years old.
• All included patients required to sign an informed consent form.
• the patients didn't receive treatment before.

Exclusion criteria

• The patients with the application of hormone or other immunosuppressive agents;
• The patients didn't want to signed informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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404 participants in 3 patient groups

IVIG(1g/kg,once)

Experimental group

Description:

The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once.

Treatment:

Drug: IVIG (1g/kg,once)

IVIG(1g/kg,twice)

Experimental group

Description:

The KD children will be randomly assigned to three groups. The patients in group B will receive IVIG 1g/kg for 2 days continuousl.

Treatment:

Drug: IVIG (1g/kg,twice)

IVIG(2g/kg.once)

Active Comparator group

Description:

The KD children will be randomly assigned to three groups. The patients in group A will receive IVIG 2g/kg once.

Treatment:

Drug: IVIG (2g/kg.once)