Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome

Sponsor
Children's Hospital of Chongqing Medical University
Study ID
NCT05843968
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nephrotic Syndrome in Children

Eligibility Criteria

Sex
ALL
Age
3 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    2 doses of rituximab 375 mg/m\^2(maximum 500mg/day) at 6 months intervals. Half an hour before rituximab infusion: oral acetaminophen 15mg/kg, oral or intramuscular antihistamine, methylprednisolone 2mg/kg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.
  • Mycophenolate Mofetil — DRUG
    Mycophenolate Mofetil 20-30 mg/kg/day BID,then adjust the dosage of drugs(maximum 2g/day) to maintian the concentration for MPA-AUC is 30-50μg.h/ml. Total duration:1year. Steroids dose:1.5mg/kg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg/kg every 2 weeks

Study Details

The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).

Key Dates

Start date
Jan 29, 2023
Status verified
Apr 2024
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    2 doses of rituximab 375 mg/m\^2 (Maximum 500mg/day)at 6 months intervals
  • Active Comparator: Mycophenolate Mofetil
    MMF 20\~30mg/kg/day，BID

Primary Outcome Measure

12-month relapse-free survival rate [ Time Frame: 12 months ]

Central Contacts

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