Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.

Eligibility criteria

Qualifiers

New-onset idiopathic nephrotic syndrome

Glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.

Disqualifiers

Glomerular hematuria: Urine red blood cell counts≥ 10/high power field(HP), ≥ 3 times within 2 weeks;

Continuous hypocomplementaemia(< 0.9g/L) ;

Repeated or persistent Hypertension(systolic and/or diastolic blood pressures measured greater than the 95th percent of blood pressure in children matching sex, age and height ≥3 different time points)

Diagnosis of secondary NS, such as secondary to Systemic Lupus Erythematosus, Immunoglobulin A Vasculitis(IgAV), diabetes, Hepatitis B virus(HBV) infection, etc.

Trial design

Treatments tested in this trial

  • Rituximab
  • Steroid

Treatment groups

80 Participants
are divided into 2 treatment groups