Follow-up on Rituximab treatment for children's nephrotic syndrome
Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
This study looks at how well rituximab works and its safety for children with hard-to-treat nephrotic syndrome by reviewing their past treatment data.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06530004 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of rituximab in children diagnosed with refractory nephrotic syndrome. It involves a retrospective analysis of clinical data from patients treated with rituximab at the First Affiliated Hospital of Xiamen University over a period of at least one year. Key outcomes include relapse-free survival, frequency of relapses, and adverse reactions associated with the treatment. The study also compares different treatment regimens and analyzes risk factors for recurrence of nephropathy post-treatment.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old with a clinical diagnosis of refractory nephrotic syndrome who have complete clinical data.
Not a fit: Patients with congenital or secondary nephrotic syndrome, severe infections, or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment strategies for children suffering from nephrotic syndrome, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with rituximab in treating nephrotic syndrome, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xiamen, Fujian
- First affiliated hospital of xiamen university — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Bai HaiTao, doctor
- Email: baihaitao@163.com
- Phone: 13779985336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.