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

PHASE2RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 29, 2023

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2026

Conditions
Nephrotic Syndrome in Children
Interventions
DRUG

Rituximab

"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."

DRUG

Mycophenolate 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"

Trial Locations (1)

400014

RECRUITING

Children's Hospital of Chongqing Medical University, Chongqing

All Listed Sponsors
lead

Children's Hospital of Chongqing Medical University

OTHER