Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome

NCT07049172 | Completed

• 1 other identifier: WX19Q09
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rituximab; targeted nursing care; pediatric nephrotic syndrome; tacrolimus; steroid-dependent nephrotic syndrome; frequently relapsing nephrotic syndrome

Outcome Measures

Primary Outcomes (2)

• Total Effective Rate

  The percentage of participants who achieved a "Significantly effective" or "Effective" response. Efficacy is defined based on remission status, renal function, and proteinuria levels. Total effective rate is calculated as the number of (Significantly effective + Effective) cases divided by the total number of cases in the group.

  At 6 months post-treatment initiation.

• Recurrence Rate

  Relapse defined as urinary protein ≥2+ or urinary protein quantity \>50 mg/kg (or urine protein/creatinine ratio \>2.0 mg/mg), occurring on three consecutive days within a 7-day period, after having achieved remission.

  Within the 6-month follow-up period after treatment initiation.

Secondary Outcomes (2)

• Change in Quality of Life as Assessed by the Children's Subjective Quality of Life Questionnaire (IS-LQ)

  Baseline and at 6 months post-treatment initiation.

• Adverse Reactions

  During the 6-month study period.

Other Outcomes (1)

• Peripheral Blood CD19+ B-Cell Count

  Monitored monthly in the study group during the 6-month follow-up.

Study Arms (2)

Rituximab with Targeted Nursing Care

EXPERIMENTAL

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

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

Tacrolimus with Targeted Nursing Care

ACTIVE COMPARATOR

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

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

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.

Also known as: Rituxan®

Rituximab with Targeted Nursing Care

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.

Rituximab with Targeted Nursing Care; Tacrolimus with Targeted Nursing Care

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.

Rituximab with Targeted Nursing Care; Tacrolimus with Targeted Nursing Care

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.

Also known as: Prograf®

Tacrolimus with Targeted Nursing Care

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Children's Hospital: lead

Study Sites (1)

Wuhan Children's Hospital

Wuhan, Hubei, 430015, China

Location

Related Publications (1)

• He L, Mei H, Gu Y, Liu Z, Yang L, Li X, Wang X, Xu T. Combined impact of rituximab and target care on efficacy, quality of life, adverse reactions and recurrence rate in children with nephrotic syndrome: a randomized controlled trial. BMC Pediatr. 2025 Sep 24;25(1):691. doi: 10.1186/s12887-025-06070-0.

  PMID: 40993587 DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Rituximab; Tacrolimus

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 3, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 1, 2025

Record last verified: 2025-06

Locations

CN (1)