Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 9, 2023

Primary Completion Date

December 25, 2025

Study Completion Date

July 30, 2026

Conditions
Nephrotic Syndrome in ChildrenRituximab
Interventions
DRUG

Rituximab

Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days), associated with trimethoprim-sulfamethoxazole(25-50 mg/kg/day orally twice per day, 3 days per week. If the patient is not allergic) for three months from the first rituximab dosing date(Day 1). Four doses of rituximab are necessary whether the patient achieves complete remission.

DRUG

Steroid

Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks. Vitamin D and calcium(adjusted according to the blood calcium level) were administered for three months.

Trial Locations (1)

Unknown

RECRUITING

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

The Children's Hospital of Zhejiang University School of Medicine

OTHER