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

Condition(s) studied

Investigational drug(s) / intervention(s)

Rituximab: 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 summary

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.

Eligibility

Primary outcome measure(s)

• The median relapse-free survival — 1 year
  The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared.
• Different sequential group curative effect evaluation — 1 year
  After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。

Trial sites (1)

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