Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

Wuhan Children's Hospital

Status: Completed

Conditions: Nephrotic Syndrome in Children

Treatments: Behavioral: Targeted Nursing Care; Drug: Rituximab; Drug: Tacrolimus; Drug: Baseline Glucocorticoid Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07049172

WX19Q09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Rituximab with Targeted Nursing Care

Experimental group

Description:

Patients received intravenous rituximab in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program

Treatment:

Drug: Baseline Glucocorticoid Therapy

Drug: Rituximab

Behavioral: Targeted Nursing Care

Tacrolimus with Targeted Nursing Care

Active Comparator group

Description:

Patients received oral tacrolimus capsules in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program identical to the study group.

Treatment:

Drug: Baseline Glucocorticoid Therapy

Drug: Tacrolimus

Behavioral: Targeted Nursing Care