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Recruiting NCT06530004

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

Trial Parameters

Condition Nephrotic Syndrome
Sponsor The First Affiliated Hospital of Xiamen University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 1 Year
Max Age 18 Years
Start Date 2020-03-01
Completion 2026-03-01
Interventions
Rituximab

Brief 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 Criteria

Inclusion Criteria: * Children clinically diagnosed with FRNS/SDNS/SRNS with complete clinical data; * age \< 18 years old; * For the first time using RTX treatment, and used in nephrotic syndrome ease; * The follow-up for 1 year or more. Exclusion Criteria: * Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis, etc.); * Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases; * Estimated glomerular filtration rate (GFR) \<60mL/min/1.73m2.

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