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

July 29, 2024 updated by: Bai Haitao, MD, The First Affiliated Hospital of Xiamen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sequential prevention group
According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.
Drug: Rituximab
B lymphocyte reconstitution was performed regularly after the administration of rituximab, and 1-4 doses of rituximab were given according to the exhaustion of B cells in children.
Recurrent sequential group
In patients with recurrence after the use of rituxan, each 375 mg/m2.
Drug: Rituximab
B lymphocyte reconstitution was performed regularly after the administration of rituximab, and 1-4 doses of rituximab were given according to the exhaustion of B cells in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The median relapse-free survival
Time Frame: 1 year
The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared.
1 year
Different sequential group curative effect evaluation
Time Frame: 1 year
After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for renal disease recurrence after RTX treatment.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XDFY-EK-BHT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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