RecruitingPhase 2NCT05843968

Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome

Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial


Sponsor

Children's Hospital of Chongqing Medical University

Enrollment

46 participants

Start Date

Jan 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).


Eligibility

Min Age: 3 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mycophenolate Mofetil and a drug called Rituximab for people with nephrotic syndrome in children. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 16 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

2 doses of rituximab 375 mg/m\^2(maximum 500mg/day) at 6 months intervals. Half an hour before rituximab infusion: oral acetaminophen 15mg/kg, oral or intramuscular antihistamine, methylprednisolone 2mg/kg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.

DRUGMycophenolate Mofetil

Mycophenolate Mofetil 20-30 mg/kg/day BID,then adjust the dosage of drugs(maximum 2g/day) to maintian the concentration for MPA-AUC is 30-50μg.h/ml. Total duration:1year. Steroids dose:1.5mg/kg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg/kg every 2 weeks


Locations(1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT05843968


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