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

NCT03200561 | Unknown Phase 3

• 1 other identifier: 201308036MIND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• maximal coronary z score

  echocardiography

  one month

Secondary Outcomes (1)

• fever more than 38 degree

  3 days

Study Arms (2)

S group

ACTIVE COMPARATOR

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

Drug: Prednisolone; Biological: immunoglobulin

I group

PLACEBO COMPARATOR

IVIG (2g/Kg in 12 hours)

Biological: immunoglobulin

Interventions

Prednisolone DRUG

Prednisolone 2mg/Kg/day for 5 days

S group

immunoglobulin BIOLOGICAL

immunoglobulin 2g/Kg for 12 hours

I group; S group

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 400, Taiwan

RECRUITING

Related 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.

  PMID: 23485027 BACKGROUND

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Prednisolone; Immunoglobulins

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ming-Tai Lin, MD, PhD

  National Taiwan University Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

• Mei-Hwan Wu, MD, PhD

  National Taiwan University Hospital, Taipei, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Ming-Tai Lin, MD, PhD

CONTACT

886-2-23123456; mingtailin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: June 27, 2017
• Study Start: October 17, 2013
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

TW (1)