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Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

NCT07049172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Nephrotic Syndrome in Children

Interventions

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.

Sponsors & Collaborators

  • Wuhan Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049172 on ClinicalTrials.gov