Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 1, 2018

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
Membranous Nephropathy - PLA2R Induced
Interventions
DRUG

Rituximab, Cyclophosphamide, and Corticosteroids

"1. Rituximab (RTX) will be given as a single intravenous (IV) dose of 375 mg/m2. Extra RTX infusion at the same dose will be administered on weeks 12, 24, and 36 in the absence of remission and the occurrence of peripheral B-cell reconstitution. Peripheral B-cell reconstitution is defined as total CD19+ cell count \>5 cells/μL;~2. Concurrent with RTX initiation, a single IV infusion of methylprednisolone 500 mg will be administrated, followed by oral prednisolone 1 mg/kg daily but not exceeding 60 mg daily during week 1. The dosage will be rapidly decreased by 10 mg/weekly as follows: week 2, 50 mg daily; week 3, 40 mg daily; week 4, 30 mg daily; week 5, 20 mg daily; weeks 6-7, 10 mg daily; weeks 8-48, 5 mg daily; week 49, stop;~3. Four IV infusions of Cyclophosphamide will be administered at a dose of 7.5 mg/kg every other week (on weeks 1, 3, 5, and 7)."

Trial Locations (1)

197022

RECRUITING

St. Petersburg State Pavlov Medical University, Saint Petersburg

All Listed Sponsors
lead

St. Petersburg State Pavlov Medical University

OTHER