Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT06530004
Status
Recruiting
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Conditions

  • Children
  • Efficacy
  • Nephrotic Syndrome
  • Rituximab

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    B lymphocyte reconstitution was performed regularly after the administration of rituximab, and 1-4 doses of rituximab were given according to the exhaustion of B cells in children.

Study Details

This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.

Key Dates

Start date
Mar 1, 2020
Status verified
Jul 2024
Primary completion
Mar 1, 2026
Completion
Mar 1, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Sequential prevention group
    According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.
  • Arm: Recurrent sequential group
    In patients with recurrence after the use of rituxan, each 375 mg/m2.

Primary Outcome Measure

The median relapse-free survival [ Time Frame: 1 year ]

Central Contacts

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