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Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

NCT04783675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-07-11

No results posted yet for this study

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.

Conditions

  • Steroid-Sensitive Nephrotic Syndrome

Interventions

DRUG

Rituximab

Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission

Sponsors & Collaborators

  • Children's Hospital of Nanjing Medical University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Anhui Provincial Children's Hospital

    collaborator OTHER

  • Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital

    collaborator UNKNOWN

  • The first affiliated hospital of Zhongshan university

    collaborator UNKNOWN

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Xuzhou Children Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2023-01-17
Completion
2023-01-17

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 NCT04783675 on ClinicalTrials.gov