RecruitingNot ApplicableNCT05679336

Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy

Rituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous Nephropathy


Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

40 participants

Start Date

May 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Rituximab, Cyclophosphamide, and Corticosteroids for people with membranous nephropathy - pla2r induced. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 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, 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).


Locations(1)

St. Petersburg State Pavlov Medical University

Saint Petersburg, Russia

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NCT05679336


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