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

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

Sponsors

Lead Sponsor: National Taiwan University Hospital

Source 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%.

Overall Status Recruiting
Start Date October 17, 2013
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
maximal coronary z score one month
Secondary Outcome
Measure Time Frame
fever more than 38 degree 3 days
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Prednisolone

Description: Prednisolone 2mg/Kg/day for 5 days

Arm Group Label: S group

Intervention Type: Biological

Intervention Name: immunoglobulin

Description: immunoglobulin 2g/Kg for 12 hours

Eligibility

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: 20 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Ming-Tai Lin, MD, PhD

Phone: 886-2-23123456

Phone Ext.: 71734

Email: [email protected]

Location
Facility: Status: Contact: China Medical University Hospital Jeng-Sheng Chang, MD 886-4-22052121 4646 [email protected]
Location Countries

Taiwan

Verification Date

June 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: S group

Type: Active Comparator

Description: IVIG (2g/Kg in 12 hours)+oral prednisolone (2mg/Kg/day for 5 days)

Label: I group

Type: Placebo Comparator

Description: IVIG (2g/Kg in 12 hours)

Acronym RAST
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov