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

NCT06530004 | Recruiting FDA Drug

• 1 other identifier: XDFY-EK-BHT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrotic Syndrome; Rituximab; Children; Efficacy

Outcome Measures

Primary Outcomes (2)

• The median relapse-free survival

  The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared.

  1 year

• Different sequential group curative effect evaluation

  After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。

  1 year

Secondary Outcomes (1)

• Risk factors for renal disease recurrence after RTX treatment.

  1 year

Study Arms (2)

Sequential prevention group

According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.

Drug: Rituximab

Recurrent sequential group

In patients with recurrence after the use of rituxan, each 375 mg/m2.

Drug: Rituximab

Interventions

Rituximab DRUG

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; Sequential prevention group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

First affiliated hospital of xiamen university

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Bai HaiTao, doctor

CONTACT

13779985336; baihaitao@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 31, 2024
• Study Start: March 1, 2020
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (1)