Rituximab in the First Episode of Paediatric Nephrotic Syndrome

Phase 3 Not yet recruiting 138 enrolled Children's Hospital of Fudan University Shanghai Children's Hospital · collab Shanghai Children's Medical Center · collab Shanghai Shen Kang Hospital Development Center · collab Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.

Timeline

Start: 2025-03-01
Primary completion: 2026-07-30
Completion: 2026-12-28

Publications

Results Liu J, Shen Q, Xie L, Wang J, Li Y, Chen J, Fang X, Tang X, Qian B, Xu H. Protocol for an open-label, single-arm, multicentre clinical study to evaluate the efficacy and safety of rituximab in the first episode of paediatric idiopathic nephrotic syndrome. BMJ Open. 2022 Oct 12;12(10):e064216. doi: 10.1136/bmjopen-2022-064216.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Prednisolone	Other / unclassified	1.5 mg/kg	—
Background	Prednisone	Other / unclassified	—	—

Rituximab in the First Episode of Paediatric Nephrotic Syndrome

Summary

Timeline

Publications

Drugs

Indications