drugset / Trial / NCT04783675
Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
Phase 2
Completed
44 enrolled
Children's Hospital of Fudan University
Anhui Provincial Children's Hospital · collabChildren's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital · collabChildren's Hospital of Nanjing Medical University · collabShandong Provincial Hospital · collabThe first affiliated hospital of Zhongshan university · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabXuzhou Children Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of subsequent relapse during 12-month of follow-up.
Timeline
- Start
- 2021-04-13
- Primary completion
- 2023-01-17
- Completion
- 2023-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |