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

Recruiting

• Conditions: Nephrotic Syndrome; Efficacy; Rituximab; Children
• Interventions: Drug: Rituximab

• Registration Number: NCT06530004
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2024-06-14
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2026-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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。

Secondary Outcome Measures

Name	Time	Method
Risk factors for renal disease recurrence after RTX treatment.	1 year	Multivariate cox analysis was used to analyze the risk factors of relapse after rituximab treatment in children with nephrotic syndrome by including gender, age of onset of nephrotic syndrome, course of disease before rituximab, history of immunosuppressive therapy, age of rituximab treatment, and maintenance immunosuppressive therapy after rituximab.

Trial Locations

Locations (1)

First affiliated hospital of xiamen university; 🇨🇳 Xiamen, Fujian, China