Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

Sponsor
Wuhan Children's Hospital
Study ID
NCT07049172
Status
Completed

Conditions

  • Nephrotic Syndrome in Children

Eligibility Criteria

Sex
ALL
Age
6 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    * 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.
  • Targeted Nursing Care — BEHAVIORAL
    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.
  • Baseline Glucocorticoid Therapy — DRUG
    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.
  • Tacrolimus — DRUG
    * 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Jun 2025
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab with Targeted Nursing Care
    Patients received intravenous rituximab in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program
  • Active Comparator: Tacrolimus with Targeted Nursing Care
    Patients received oral tacrolimus capsules in conjunction with baseline glucocorticoid therapy and a standardized targeted nursing care program identical to the study group.

Primary Outcome Measure

Total Effective Rate [ Time Frame: At 6 months post-treatment initiation. ]

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