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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-16
SponsorChildren's Hospital of Chongqing Medical University

About this trial

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).

Eligibility criteria

Qualifiers

Children with a definite diagnosis of SDNS are included in the study during relapse treatment.

Age 3-16 years.

Steroid dependent dose≤0.3mg/kg/day.

Cumulative steroid use for ≥6 months.

Disqualifiers

Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc.

Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased.

Diagnosis of hereditary nephrotic syndrome.

Full dose of prednisone (2mg/kg/day, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative.

Trial design

Treatments tested in this trial

  • Rituximab
  • Mycophenolate Mofetil

Treatment groups

46 Participants
are divided into 2 treatment groups