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Rituximab in the First Episode of Paediatric Nephrotic Syndrome

NCT05850546 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-01-22

No results posted yet for this study

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.

Conditions

  • Steroid-Sensitive Nephrotic Syndrome

Interventions

DRUG

Rituximab

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

DRUG

Corticosteroid

guideline-recommended corticosteroid therapy

Sponsors & Collaborators

  • Shanghai Shen Kang Hospital Development Center

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Children's Medical Center

    collaborator OTHER

  • Shanghai Children's Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Qian Shen · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05850546 on ClinicalTrials.gov