A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)

Phase 3

• Conditions: Steroid; Immuoglobulin; Kawasaki Disease
• Interventions: Drug: Prednisolone; Biological: immunoglobulin

• Registration Number: NCT03200561
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Background:

Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are currently standard treatment. However, 10-15% of KD patients have poor response to such treatment and suffer from higher risk of coronary involvement. Recently, combination of prednisolone and IVIG has been shown effective to lower the chance of refractory to IVIG treatment and subsequent coronary lesions. However, no randomized trial on the steroid efficacy was ever conducted in Taiwan.

Aim:

Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in the refractory KD children.

Methods:

For the KD patients with fever persisted or relapsed 24 hours after the ending of IVIG infusion, they will be randomized into two group: IVIG group (I) and IVIG + prednisolone group (P). The KD patients in the P group will have in addition to IVIG, oral prednisolone 2mg/kg/day for at least 5 days. The difference in the response rate and percentage of coronary involvement will be compared between I and P groups.

Predicted results:

We plan to enroll 100 refractory KD patients, 50 patients for each group. We predict the risk of coronary involvement can be reduced from 30% to 15%.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-17
• Status Verified: 2017-06
• Study First Submitted: 2017-06-25
• Study First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Study First Posted: 2017-06-27
• Last Update Posted: 2017-06-27
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• KD (Kawasaki disease) patients who failed to respond to the initial IVIG as those who had persistent fever that lasted for more than 24 hours (nonresponse to the initial IVIG) or recrudescent fever associated with KD symptoms after an afebrile period (relapse).

Exclusion Criteria

• KD patients, those diagnosed on or after day 9 of illness (the first illness day was defined as the day of fever onset), those with coronary artery abnormalities before enrolment, those who were afebrile before enrolment, those who had received steroids (oral, intravenous, intramuscular, or subcutaneous) in the 30 days before the study or intravenous immunoglobulin in the previous 180 days, those with concomitant severe medical disorders (eg, immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases), and those with suspected infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S group	Prednisolone	IVIG (2g/Kg in 12 hours)+oral prednisolone (2mg/Kg/day for 5 days)
S group	immunoglobulin	IVIG (2g/Kg in 12 hours)+oral prednisolone (2mg/Kg/day for 5 days)
I group	immunoglobulin	IVIG (2g/Kg in 12 hours)

Primary Outcome Measures

Name	Time	Method
maximal coronary z score	one month	echocardiography

Secondary Outcome Measures

Name	Time	Method
fever more than 38 degree	3 days	from end of second course of IVIG

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan