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

NCT ID: NCT03200561

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-17
• Study Completion Date: 2020-12-31

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%.

Conditions

Kawasaki Disease; Steroid; Immuoglobulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S group

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

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

Prednisolone 2mg/Kg/day for 5 days

immunoglobulin

Intervention Type: BIOLOGICAL

immunoglobulin 2g/Kg for 12 hours

I group

IVIG (2g/Kg in 12 hours)

Group Type: PLACEBO_COMPARATOR

immunoglobulin

Intervention Type: BIOLOGICAL

immunoglobulin 2g/Kg for 12 hours

Interventions

Prednisolone

Prednisolone 2mg/Kg/day for 5 days

Intervention Type: DRUG

immunoglobulin

immunoglobulin 2g/Kg for 12 hours

Intervention Type: BIOLOGICAL

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.

• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Tai Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Taipei, Taiwan

Mei-Hwan Wu, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital, Taipei, Taiwan

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Tai Lin, MD, PhD

Role: CONTACT

mingtailin@ntu.edu.tw

886-2-23123456 ext. 71734

Facility Contacts

Jeng-Sheng Chang, MD

Role: primary

d0669@mail.cmuh.org.tw

886-4-22052121 ext. 4646

References

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.

Reference Type: BACKGROUND

PMID: 23485027 (View on PubMed)

Other Identifiers

201308036MIND

Identifier Type: -

Identifier Source: org_study_id