A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study) (RAST)
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|ClinicalTrials.gov Identifier: NCT03200561|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
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.
Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in the refractory KD children.
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.
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%.
|Condition or disease||Intervention/treatment||Phase|
|Kawasaki Disease Steroid Immuoglobulin||Drug: Prednisolone Biological: immunoglobulin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||October 17, 2013|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: S group
IVIG (2g/Kg in 12 hours)+oral prednisolone (2mg/Kg/day for 5 days)
Prednisolone 2mg/Kg/day for 5 days
immunoglobulin 2g/Kg for 12 hours
Placebo Comparator: I group
IVIG (2g/Kg in 12 hours)
immunoglobulin 2g/Kg for 12 hours
- maximal coronary z score [ Time Frame: one month ]echocardiography
- fever more than 38 degree [ Time Frame: 3 days ]from end of second course of IVIG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200561
|Contact: Ming-Tai Lin, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|China Medical University Hospital||Recruiting|
|Taichung, Taiwan, 400|
|Contact: Jeng-Sheng Chang, MD 886-4-22052121 ext 4646 email@example.com|
|Principal Investigator:||Ming-Tai Lin, MD, PhD||National Taiwan University Hospital, Taipei, Taiwan|
|Study Director:||Mei-Hwan Wu, MD, PhD||National Taiwan University Hospital, Taipei, Taiwan|