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

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT05734794
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Nephrotic Syndrome in Children
  • Rituximab

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days), associated with trimethoprim-sulfamethoxazole(25-50 mg/kg/day orally twice per day, 3 days per week. If the patient is not allergic) for three months from the first rituximab dosing date(Day 1). Four doses of rituximab are necessary whether the patient achieves complete remission.
  • Steroid — DRUG
    Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks. Vitamin D and calcium(adjusted according to the blood calcium level) were administered for three months.

Study Details

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.

Key Dates

Start date
Feb 9, 2023
Status verified
Aug 2023
Primary completion
Dec 25, 2025
Completion
Jul 30, 2026

Study Design

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

Arms

  • Experimental: Rituximab Group
    Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days).
  • Active Comparator: Steroid Group
    Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks.

Primary Outcome Measure

Recurrence-free survival time(day) after first complete remission [ Time Frame: From complete remission to 52 weeks ]

Central Contacts

Related Studies