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RECRUITING
NCT05514015
PHASE4

Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This was a prospective, randomized, multicenter clinical trial. Seventy-eight patients with primary membranous nephropathy (PMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with corticosteroids in induction therapy and the control group was given rituximab monotherapy. After 6 months, patients who had decreased 24h urinary protein by \> 25% but did not achieve CR were given rituximab maintenance therapy. The complete response rate at 12 months was measured.

Official title: A Prospective, Randomized, Multicenter Clinical Trial Comparing the Efficacy and Safety of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in Primary Membranous Nephropathy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2024-03-29

Completion Date

2026-12-31

Last Updated

2024-04-02

Healthy Volunteers

No

Interventions

DRUG

rituximab combined with corticosteroids

Induction therapy: Rituximab intravenous infusion of 1g, d1, d15, combined with glucocorticoid therapy, oral prednisolone, initial dose of 0.5mg/(kg·d), once a day, after 8 weeks of treatment, reduce by 5mg every 4 weeks until 0.25mg/kg, this dose was maintained for 8 weeks, and then reduced by 2.5mg every 4 weeks, until 5-10mg is maintained, and the total course of treatment was about one year or so;

DRUG

rituximab

Control group (treated with Rituximab monotherapy treatment) :Rituximab intravenous infusion of 1g, d1, d15

Locations (1)

Wei Chen

Guangzhou, Guangdong, China