Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT05850546
PHASE3

Rituximab in the First Episode of Paediatric Nephrotic Syndrome

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Single-dose Rituximab Biosimilar in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-03-01

Completion Date

2026-12-28

Last Updated

2025-01-22

Healthy Volunteers

Yes

Interventions

DRUG

Rituximab

Rituximab 375 mg/m2 added to guideline-recommended corticosteroid therapy

DRUG

Corticosteroid

guideline-recommended corticosteroid therapy

Locations (3)

Children's hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai's Children's Medical Center

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China