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Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome | Clinical Trials | Clareo Health

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Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

Efficacy and Safety of Rituximab in Reducing Relapses in Children With Steroid-Sensitive Nephrotic Syndrome: An Open-label, Multi-center Clinical Study.

NCT07049172•Wuhan Children's Hospital

View on ClinicalTrials.gov

Summary

This study investigated the combined impact of rituximab and targeted nursing care versus tacrolimus and targeted nursing care on efficacy, quality of life, adverse reactions, and recurrence rate in children with challenging (steroid-dependent or frequently relapsing) nephrotic syndrome. Ninety-one pediatric patients were randomized to either receive rituximab plus targeted nursing or tacrolimus plus targeted nursing, and outcomes were assessed over a 6-month period.

Detailed Description

Nephrotic syndrome in children, particularly steroid-dependent (SDNS) or frequently relapsing (FRNS) types, poses significant treatment challenges. While glucocorticoids are initial mainstays, second-line immunosuppressants like tacrolimus or rituximab are often required. Rituximab, a monoclonal antibody targeting CD20 on B-lymphocytes, has shown promise. Targeted nursing care, a patient-centered approach involving joint goal-setting and personalized interventions, aims to improve adherence and overall well-being. This study aimed to evaluate the synergistic effect of rituximab therapy combined with a structured targeted nursing care program compared to tacrolimus with the same targeted nursing care. A total of 91 pediatric patients (aged 6-15 years) with SDNS or FRNS were enrolled from January 2021 to June 2023. They were randomized into a study group (n=46, rituximab + targeted nursing) and a control group (n=45, oral tacrolimus + targeted nursing). Both groups received baseline glucocorticoid therapy. The study group received intravenous rituximab (375 mg/m² weekly for 12 weeks). The control group received oral tacrolimus (0.05-0.1 mg/kg/day, adjusted to trough levels). Both groups received identical targeted nursing care protocols. Outcomes compared included clinical efficacy (remission status), quality of life (IS-LQ questionnaire), incidence of adverse reactions, and recurrence rate over a 6-month follow-up. Peripheral blood CD19+ B-cell counts were monitored in the rituximab group. The study was approved by the institutional ethics committee, and informed consent was obtained.

Eligibility

Age

6 - 15 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of primary pediatric nephrotic syndrome, specifically steroid-dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS), as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. (SDNS is defined as relapse occurring during tapering of glucocorticoids or within 14 days of discontinuation; FRNS is defined as ≥2 relapses within 6 months of initial response or ≥4 relapses in any 12-month period).
•Age between 6 and 15 years.
•Normal intellectual development and the ability to understand and communicate.
•Informed consent obtained from the guardians and assent from children capable of understanding.

Exclusion Criteria

•Steroid-resistant nephrotic syndrome (SRNS).
•Severe renal insufficiency (according to KDIGO criteria or other relevant standards).
•Cognitive or mental disorders.
•Worsening condition upon admission necessitating intensive care.
•Parents unable to provide long-term care or unwilling to participate.
•Interruption of hospitalization for any reason.
•Prior treatment with rituximab or tacrolimus.
•Co-existing significant kidney, urinary system diseases (other than NS), or severe active urinary tract infection.
•Significant liver function impairment.
•Known hypersensitivity to rituximab or tacrolimus.

Locations (1)

Wuhan Children's Hospital

Wuhan, Hubei, China

Key Dates

Start Date

January 1, 2021

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2023

Last Updated

October 1, 2025

Enrollment

ACTUAL participants

Conditions

Nephrotic Syndrome in Children

Interventions

Rituximab

DRUG

Targeted Nursing Care

BEHAVIORAL

Baseline Glucocorticoid Therapy

DRUG

Tacrolimus

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

Inclusion Criteria

Exclusion Criteria

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE)

Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial

Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study

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Steroid Sensitive Nephrotic Syndrome in Children