Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial

Sponsors

Lead Sponsor: Children's Hospital of Fudan University

Collaborator: Jiangxi Province Children's Hospital
First People's Hospital of Hangzhou
Shengjing Hospital
First Hospital of Jilin University
Chengdu Women's and Children's Central Hospital
Children's Hospital of Chongqing Medical University
Inner Mongolia People's Hospital
Sichuan Provincial People's Hospital
Wuhan Union Hospital, China
Third Affiliated Hospital of Zhengzhou University
Children's Hospital Of Soochow University
Yuying Children's Hospital of Wenzhou Medical University
Beijing Children's Hospital
Qilu Hospital of Shandong University

Source Children's Hospital of Fudan University
Brief Summary

This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .

Detailed Description

This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months,and 12 months after onset of KD to assess the coronary artery lesions.

Overall Status Recruiting
Start Date January 15, 2020
Completion Date December 2021
Primary Completion Date December 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of coronary artery lesions(CAL) at one month of illness at one month of illness
Secondary Outcome
Measure Time Frame
Percentage of the need for additional treatment from admission to discharge (about 2 weeks of illness)
Duration of fever (hours) after initiation of initial IVIG infusion from initiation of initial IVIG infusion to the first record of being afebrile(defined as an axillary temperature <37.5 for more than 24 hours)
Changes in z scores of LMCA throughout the study period from admission to 12 months of illness
Changes in z scores of LAD throughout the study period from admission to 12 months of illness
Changes in z scores of LCX throughout the study period from admission to 12 months of illness
Changes in z scores of the proximal segment of RCA throughout the study period from admission to 12 months of illness
Changes in z scores of the middle segment of RCA throughout the study period from admission to 12 months of illness
Change in serum C-reactive protein (CRP) concentration from admission to 72 hours after completion of initial IVIG infusion
Number of patients with serious adverse events from admission to 3 months of illness
Enrollment 3000
Condition
Intervention

Intervention Type: Drug

Intervention Name: IVIG

Description: IVIG at a single dose of 2 g/kg, with the maximum dose of 60g

Other Name: Intravenous Immunoglobulins, Human

Intervention Type: Drug

Intervention Name: Aspirin

Description: Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

Other Name: Acetylsalicylic acid

Intervention Type: Drug

Intervention Name: Prednisolone

Description: Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days. If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.

Arm Group Label: the standard+prednisolone group

Other Name: STEROLONE

Eligibility

Criteria:

Inclusion Criteria:

- Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017

- Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)

- Not treated with IVIG yet

- Age ≥1 month

Exclusion Criteria:

- Z score of any coronary artery before initial treatment ≥10

- Receiving steroids or other immunosuppressive agents in the previous 30 days

- With a previous history of KD

- Afebrile before enrolment

- With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza

- With serious immune diseases such as immunodeficiency or chromosomal abnormalities

Gender: All

Minimum Age: 1 Month

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Fang Liu, MD. Study Director Children's Hospital of Fudan University
Overall Contact

Last Name: Fang Liu, MD.

Phone: +86 021-64932800

Email: [email protected]

Location
Facility: Status: Contact:
Beijing Children's Hospital | Beijing, 100045, China Recruiting Qirui Li, MD
The First Hospital of Jilin University | Chang chun, 130021, China Recruiting Jinhua Piao, MD.
Sichuan Provincial People's Hospital | Chengdu, 610072, China Recruiting Qian Peng, MD.
Chengdu Women's and Children's Central Hospital | Chengdu, 610074, China Recruiting Yiling Liu, MD.
Children's Hospital of Chongqing Medical University | Chongqing, 400014, China Recruiting Xiaoyan Liu, MD.
Hangzhou First people's Hospital | Hangzhou, 310006, China Recruiting Xianmei Huang, MD.
Inner Mongolia People's Hospital | Hohhot, 010017, China Recruiting Hua Zhu, MD.
Qilu Hospital of Shandong University | Jinan, 250012, China Recruiting Cuifen Zhao, MD
Jiangxi Provincial Children's Hospital | Nanchang, 330006, China Recruiting Xiaohui Liu, MD.
Children's Hospital of Fudan University | Shanghai, 201102, China Recruiting Fang Liu, MD.
Shengjing Hospital of China Medical University | Shenyang, 110004, China Recruiting Ce Wang, MD.
Children's hospital of Soochow University | Suzhou, 215003, China Not yet recruiting Haitao Lv, MD.
Yuying Children's Hospital of Wenzhou Medical University | Wenzhou, 325027, China Not yet recruiting Rongzhou Wu, MD
Union Hospital,Tongji Medical College of Huazhong University of Science and Technology | Wuhan, 430022, China Recruiting Qiupeng Wang, MD.
The Third Affiliated Hospital of ZhengzhouUniversity | Zhengzhou, 450052, China Not yet recruiting Yan Li, MD.
Location Countries

China

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: the standard group

Type: Active Comparator

Description: IVIG 2g/kg once, given within 12 to 24 hours; Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

Label: the standard+prednisolone group

Type: Experimental

Description: IVIG 2g/kg once, given within 12 to 24 hours; Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness. Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses) for 3 days, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days . If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Participants and physicians will not be masked to the assignment. Pediatric cardiologists who assess coronary artery lesions (CAL) by echocardiography will be masked to the allocation.

Source: ClinicalTrials.gov