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

Kawasaki Disease Clinical Trial

— RAST  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03200561
• Other study ID #: 201308036MIND
• Status: Recruiting
• Phase: Phase 3
• First received: June 25, 2017
• Last updated: June 26, 2017
• Start date: October 17, 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2017
• Source: National Taiwan University Hospital
• Contact: Ming-Tai Lin, MD, PhD
• Phone: 886-2-23123456
• Email: mingtailin[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immuoglobulin
• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome
• Steroid

Intervention

Drug:
• Prednisolone
Prednisolone 2mg/Kg/day for 5 days

Biological:
• immunoglobulin
immunoglobulin 2g/Kg for 12 hours

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Kobayashi T, Kobayashi T, Morikawa A, Ikeda K, Seki M, Shimoyama S, Ishii Y, Suzuki T, Nakajima K, Sakamoto N, Arakawa H. Efficacy of intravenous immunoglobulin combined with prednisolone following resistance to initial intravenous immunoglobulin treatment of acute Kawasaki disease. J Pediatr. 2013 Aug;163(2):521-6. doi: 10.1016/j.jpeds.2013.01.022. Epub 2013 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal coronary z score	echocardiography	one month
Secondary	fever more than 38 degree	from end of second course of IVIG	3 days