drugset / Trial / NCT04078568
Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
Phase 3
Completed
3208 enrolled
Children's Hospital of Fudan University
Beijing Children's Hospital · collabChengdu Women's and Children's Central Hospital · collabChildren's Hospital of Chongqing Medical University · collabChildren's Hospital of Soochow University · collabFirst People's Hospital of Hangzhou · collabInner Mongolia People's Hospital · collabJiangxi Province Children's Hospital · collabQilu Hospital of Shandong University · collabShengjing Hospital · collabSichuan Provincial People's Hospital · collabThe First Hospital of Jilin University · collabThird Affiliated Hospital of Zhengzhou University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabYuying Children's Hospital of Wenzhou Medical University · collab
RandomizedParallel-groupSingle-blindTreatment
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) .
Timeline
- Start
- 2020-01-15
- Primary completion
- 2024-12-30
- Completion
- 2025-11-06
Outcome
Missed primary endpoint
paper The addition of prednisolone to standard primary treatment for Kawasaki disease did not reduce the incidence of coronary-artery lesions at 1 month after illness onset. PMID 41985133 ↗
Publications
- Lin S, He Y, He L, Liu Y, Wang F, Xiong Z, Lin Y, Ye L, Chu C, Wang F, Zhao L, Cao Y, Zheng Y, Huang Q, Wang J, Liang X, Zhao Q, Sun S, Dou Y, He W, Huang X, Sun J, Huang X, Li Y, Liao Y, Lv H, Pan S, Zhu H, An X, He X, Zhao C, Liu X, Hu Y, Piao J, Qin L, Dong X, Peng Q, Wang C, Lin S, Huang P, Wu R, Peng H, Li Z, Wang D, Liu X, Yan W, Liu F, Huang G; Chinese Kawasaki Disease Collaboration Network. Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease. N Engl J Med. 2026 Apr 16;394(15):1480-1490. doi: 10.1056/NEJMoa2511478.
- Lin SY, He L, Xie LP, Wang Y, Lin YX, Cao YY, Yan WL, Liu F, Huang GY. Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial. Trials. 2021 Dec 11;22(1):898. doi: 10.1186/s13063-021-05807-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 1.6 mg/kg | Intravenous |
| Subject | Prednisolone | Other / unclassified | 2 mg/kg | Oral |
| Background | Aspirin | Small molecule | 30 mg/kg | Oral |
| Background | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |