Different Doses of IVIG for Kawasaki Disease

Kawasaki Disease Clinical Trial

Official title:

Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439996
• Other study ID #: KD(2015-2016)
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• IVIG (1g/kg,once)
Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was =8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
• IVIG (1g/kg,twice)
Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was =8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
• IVIG (2g/kg.once)
Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was =8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Shanghai Children's Hospital, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of fever subsided to normal after initial IVIG finished	Hours of fever subsided to normal after initial IVIG finished	36 hours after IVIG finished
Primary	incidence of coronary artery lesions(CAL) after IVIG finished	incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography	start from IVIG finished, ended by the end of 2 weeks
Secondary	incidence of coronary artery lesions(CAL) after IVIG finished	incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography	start from IVIG finished, ended by the end of 1 month
Secondary	incidence of coronary artery lesions(CAL) after IVIG finished	incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography	start from IVIG finished, ended by the end of 3 month
Secondary	incidence of coronary artery lesions(CAL) after IVIG finished	incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography and coronary atery angiogram	start from IVIG finished, ended by the end of 6 month
Secondary	Total dose of immunoglobin used for every patient	Total dose of immunoglobin used for every patient	estimated about up to 10 days, start from admission,ended by discharge
Secondary	total medical cost for KD treatment during hospital stay	record the hospital duration of every patient and the medical expenses for KD	estimated about up to 10 days, start from admission,ended by discharge
Secondary	total frequency (%) of severe adverse events	Severe adverse events included death, infection or exacerbation, heart failure, allergic reaction, etc	estimated about up to 10 days, start from admission,ended by discharge