RecruitingPhase 4NCT05514015

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

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


Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

78 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for primary membranous nephropathy (PMN) — a kidney disease that causes protein to leak into urine: rituximab combined with corticosteroids versus rituximab alone. The goal is to find the safest, most effective approach with fewer side effects. You may be eligible if... - You are between 18 and 75 years old - You have a confirmed diagnosis of primary membranous nephropathy via kidney biopsy - You have significant protein in your urine (24-hour urine protein ≥ 3.5g) despite at least 3 months of ACE inhibitor or ARB treatment - Your kidney filtration rate (eGFR) is at least 30 mL/min/1.73m² - You are using contraception if female and not post-menopausal You may NOT be eligible if... - You have diabetes with kidney complications - You have secondary membranous nephropathy (caused by hepatitis, lupus, drugs, or cancer) - You have previously been treated with rituximab, steroids, or certain immunosuppressants - You have an active infection (hepatitis B or C, tuberculosis, HIV) - You are pregnant, breastfeeding, or planning pregnancy in the next 24 months - You have severely low blood counts or significantly elevated liver enzymes Talk to your doctor to see if this trial is right for you.

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 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;

DRUGrituximab

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


Locations(1)

Wei Chen

Guangzhou, Guangdong, China

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