Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
Overview
- Phase
- Not Applicable
- Intervention
- Rituximab
- Conditions
- Nephrotic Syndrome
- Sponsor
- The First Affiliated Hospital of Xiamen University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The median relapse-free survival
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Bai Haitao, MD
Director
The First Affiliated Hospital of Xiamen University
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.
Arms & Interventions
Sequential prevention group
According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.
Intervention: Rituximab
Recurrent sequential group
In patients with recurrence after the use of rituxan, each 375 mg/m2.
Intervention: Rituximab
Outcomes
Primary Outcomes
The median relapse-free survival
Time Frame: 1 year
The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared.
Different sequential group curative effect evaluation
Time Frame: 1 year
After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。
Secondary Outcomes
- Risk factors for renal disease recurrence after RTX treatment.(1 year)