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

Conditions

• Frequently Relapsing Nephrotic Syndrome
• Steroid-Dependent Nephrotic Syndrome

Eligibility Criteria

Sex

ALL

Age

1 Year - 16 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Rituximab: 375 mg/m2 intravenously on day 0 and day 7
• Mycophenolate Mofetil — DRUG
  Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.
• Placebo tablets matching Mycophenolate Mofetil — DRUG
  Addition of Maintenance Placebo tablets matching Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

Study Details

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

Key Dates

Start date

Jan 1, 2021

Status verified

Dec 2020

Primary completion

Sep 1, 2022

Completion

Oct 1, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab and Mycophenolate Mofetil
  First course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.
• Placebo Comparator: Rituximab Only
  First course Course Rituximab at Randomization. Addition of Maintenance Placebo tablets matching Mycophenolate mofetil from 4 Month onwards.

Primary Outcome Measure

1-year relapse-free survival rate [ Time Frame: 1-year period after randomization ]