Rituximab in the First Episode of Paediatric Nephrotic Syndrome

Sponsor
Children's Hospital of Fudan University
Study ID
NCT05850546
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Steroid-Sensitive Nephrotic Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m2 added to guideline-recommended corticosteroid therapy
  • Corticosteroid — DRUG
    guideline-recommended corticosteroid therapy

Study Details

The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.

Key Dates

Start date
Mar 1, 2025
Status verified
Jan 2025
Primary completion
Jul 30, 2026
Completion
Dec 28, 2026

Study Design

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

Arms

  • Experimental: Rituximab
    Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission. The prednisolone at a dose of 2 mg/kg per day (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for the next 6 weeks; therapy is then discontinued.
  • Other: Routine Therapy
    The prednisolone at a dose of 2 mg/kg per day (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for the next 6 weeks; therapy is then discontinued.

Primary Outcome Measure

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

Central Contacts