NCT06530004 Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
| NCT ID | NCT06530004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Nephrotic Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06530004 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Nephrotic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06530004 currently recruiting?
Yes, NCT06530004 is actively recruiting participants. Contact the research team at baihaitao@163.com for enrollment information.
Where is the NCT06530004 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06530004 clinical trial?
NCT06530004 is sponsored by The First Affiliated Hospital of Xiamen University. The trial plans to enroll 50 participants.