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

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Brief Title

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

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)

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%.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

maximal coronary z score

Secondary Outcome

 fever more than 38 degree

Condition

Kawasaki Disease

Intervention

Prednisolone

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

October 17, 2013

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

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

Ages

N/A - 20 Years

Accepts Healthy Volunteers

No

Contacts

Ming-Tai Lin, MD, PhD, 886-2-23123456, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT03200561

Organization ID

201308036MIND


Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital


Study Sponsor

Ming-Tai Lin, MD, PhD, Principal Investigator, National Taiwan University Hospital, Taipei, Taiwan


Verification Date

June 2017