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NCT Number: NCT06530004

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

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.

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Key information

Conditions

Nephrotic Syndrome Children Efficacy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Rituximab Urogenital Diseases Urologic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First affiliated hospital of xiamen university

Xiamen, Fujian, 361003, China

Location status: Recruiting

Location contact

Bai HaiTao, doctor

CONTACT

[email protected]

13779985336

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The median relapse-free survival

    Time frame: 1 year

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

  2. Different sequential group curative effect evaluation

    Time frame: 1 year

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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bai HaiTao, doctor

CONTACT

[email protected]

13779985336

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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