Different Doses of IVIG for Kawasaki Disease

NCT02439996 | Completed Phase 3 DMC

• 1 other identifier: KD(2015-2016)
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kawasaki Disease

Keywords

Kawasaki disease IVIG

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• incidence of coronary artery lesions(CAL) after IVIG finished

  start from IVIG finished, ended by the end of 1 month

• incidence of coronary artery lesions(CAL) after IVIG finished

  start from IVIG finished, ended by the end of 3 month

• incidence of coronary artery lesions(CAL) after IVIG finished

  start from IVIG finished, ended by the end of 6 month

• Total dose of immunoglobin used for every patient

  estimated about up to 10 days, start from admission,ended by discharge

• total medical cost for KD treatment during hospital stay

  estimated about up to 10 days, start from admission,ended by discharge

Study Arms (3)

IVIG(1g/kg,once)

EXPERIMENTAL

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

Drug: IVIG (1g/kg,once)

IVIG(1g/kg,twice)

EXPERIMENTAL

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

Drug: IVIG (1g/kg,twice)

IVIG(2g/kg.once)

ACTIVE COMPARATOR

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

Drug: IVIG (2g/kg.once)

Interventions

IVIG (1g/kg,once) DRUG

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.

Also known as: Asprin

IVIG(1g/kg,once)

IVIG (1g/kg,twice) DRUG

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.

Also known as: Asprin

IVIG(1g/kg,twice)

IVIG (2g/kg.once) DRUG

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.

Also known as: Asprin

IVIG(2g/kg.once)

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Children's Medical Center: collaborator
• Shanghai Children's Hospital: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• He L, Liu F, Yan W, Huang M, Huang M, Xie L, Guo Y, Xu X, Chu C, Wu L, Liang X, Sun S, Wang F, Zhao L, Zhao Q, Ma X, Xie L, Huang G. Randomized trial of different initial intravenous immunoglobulin regimens in Kawasaki disease. Pediatr Int. 2021 Jul;63(7):757-763. doi: 10.1111/ped.14656. Epub 2021 Jun 16.

  PMID: 33600060 DERIVED

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Immunoglobulins, Intravenous; acetylsalicylic acid lysinate

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Guoying Huang, PHD

  Children Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,President

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

CN (1)