Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT05679336
Status
Unknown

Conditions

  • Membranous Nephropathy - PLA2R Induced

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Cyclophosphamide, and Corticosteroids — DRUG
    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).

Study Details

This exploratory study aims to assess the efficacy, safety of the experimental treatment based on a combination of rituximab (RTX), intravenous (IV) cyclophosphamide (CYC), and corticosteroids (S) administrated at lower cumulative doses (RCP) for the induction of early remission in subjects with anti-PLA2R antibody-positive primary membranous nephropathy (PMN) having nephrotic syndrome (NS).

Key Dates

Start date
May 1, 2018
Status verified
May 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab, Cyclophosphamide, and Corticosteroids group
    The experimental treatment group: 40 participants will receive combined immunosuppressive therapy with Rituximab, Cyclophosphamide, and Corticosteroids.

Primary Outcome Measure

Partial clinical remission (PR) and complete clinical remission (CR) [ Time Frame: Up to 1 year ]

Central Contacts