NCT07049172

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Wuhan Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrotic Syndrome in Children

Interventions

Type	Name	Description
DRUG	Rituximab	* Dosage: 375 mg/m² * Route: Intravenous infusion * Frequency: Once a week * Duration: 12 consecutive weeks * Details: Diluted in 5% glucose solution. Infusion started at 25 ml/h, increased by 25 ml/h every 30 minutes if no adverse reactions, up to 100-150 ml/h.
BEHAVIORAL	Targeted Nursing Care	A structured, individualized nursing approach involving joint goal-setting. Included health education, psychological support, relaxation techniques, dietary care, lifestyle guidance, complication management, and medication guidance. Delivered throughout hospital stay and reinforced during monthly follow-ups.
DRUG	Baseline Glucocorticoid Therapy	Patients already on maintenance glucocorticoids continued their regimen. For relapse at admission, IV methylprednisolone (2 mg/kg/day), then oral prednisone (2 mg/kg/day, max 60mg/day) tapered according to standard protocols.
DRUG	Tacrolimus	* Dosage: Initial dose 0.05-0.1 mg/kg/day, adjusted to maintain target trough levels of 5-10 ng/mL. * Route: Oral * Frequency: Divided into two doses (morning and evening) * Duration: Throughout the 6-month study period.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2025-07-03
• Last updated: 2025-10-01

Locations

1 site across 1 country: China