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Randomized Trial Evaluating Mycophenolate Mofetil in Children With Nephrotic Syndrome After Rituximab Treatment

NCT04531865 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-12-29

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy and safety of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 12 months among Children with frequently-relapsing or steroid-dependent nephrotic syndrome

Conditions

  • Frequently Relapsing Nephrotic Syndrome
  • Steroid-Dependent Nephrotic Syndrome

Interventions

DRUG

Rituximab

Rituximab: 375 mg/m2 intravenously on day 0 and day 7

DRUG

Mycophenolate Mofetil

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

DRUG

Placebo tablets matching Mycophenolate Mofetil

Addition of Maintenance Placebo tablets matching Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

Sponsors & Collaborators

  • 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

  • Xu Hong, PhD.MD. · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-09-01
Completion
2022-10-01

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 NCT04531865 on ClinicalTrials.gov