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
Study ID
NCT05514015
Phase
PHASE4
Status
Recruiting
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Conditions

  • Primary Membranous Nephropathy

Eligibility Criteria

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

Interventions

  • rituximab combined with corticosteroids — DRUG
    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;
  • rituximab — DRUG
    Control group (treated with Rituximab monotherapy treatment) :Rituximab intravenous infusion of 1g, d1, d15

Study Details

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.

Key Dates

Start date
Mar 29, 2024
Status verified
Apr 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention arm
    rituximab combined with corticosteroids treatment group
  • Active Comparator: Control arm
    Rituximab monotherapy treatment

Primary Outcome Measure

The complete response rate at 12 months; [ Time Frame: 12 months ]

Central Contacts

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