Actively Recruiting
Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-07-31
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on children diagnosed with refractory nephrotic syndrome who received rituximab (RTX) treatment and were followed for at least one year. It aims to evaluate the clinical effectiveness and safety of RTX by comparing relapse rates, steroid and immunosuppressant use, and adverse reactions before and after treatment. Additionally, the study analyzes risk factors for disease recurrence and assesses growth indicators and the economic impact of RTX treatment. Children in this study received RTX doses of 375 mg/m2, administered either as a preventive measure based on B cell reconstitution or after a relapse occurred. The treatment involves regular monitoring of B lymphocyte levels to determine the need for 1 to 4 doses of RTX. Two groups are observed: one receiving prophylactic RTX and the other receiving RTX after relapse. Participants' medical records were reviewed for personal and clinical data, including relapse-free survival over one year and treatment effectiveness across different groups. Researchers monitored adverse drug reactions, growth, and steroid/immunosuppressant reduction or withdrawal. The study spans from March 2020 to March 2026, with follow-up lasting at least one year to measure outcomes and safety.
CONDITIONS
Brief Title
Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children clinically diagnosed with FRNS, SDNS, or SRNS with complete clinical data
- Age under 18 years old
- First time using rituximab treatment for nephrotic syndrome
- Follow-up period of 1 year or more
You will not qualify if you...
- Congenital or infantile nephrotic syndrome or secondary nephrotic syndrome such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis
- Active hepatitis, severe infection, severe immune deficiency, or malignant diseases
- Estimated glomerular filtration rate (GFR) less than 60 mL/min/1.73m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on dosing schedule
Participants receive 1 to 4 doses of rituximab according to their B cell levels to treat nephrotic syndrome.
1 to 4 infusions depending on B cell reconstitution
Duration - 1 year or more
Participants are monitored for up to 1 year to evaluate relapse-free survival and treatment effects.
Regular follow-up visits during the monitoring period
Trial Site Locations
Total: 1 location
1
First affiliated hospital of xiamen university
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
B
Bai HaiTao, doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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