NCT05514015

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study design A prospective, randomized , multicenter clinical study Outcomes * Primary objective To evaluate the efficacy of rituximab combined with corticosteroids or rituximab monotherapy in primary membranous nephropathy * Secondary Objectives The safety of rituximab combined with corticosteroids or rituximab monotherapy in primary membranous nephropathy; Primary outcome The complete response rate at 12 months; * Secondary outcomes 1. Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response); 2. Median remission time; 3. Proportion of patients without recurrence at 12, 18 and 24 months; 4. Median non-recurrence time; 5. Cumulative dose of glucocorticoids; 6. CD19+ cell count, anti-PLA2R antibody expression level; 7. Renal function index: eGFR; 8. Incidence of adverse events; Study population Seventy-eight male or female treatment-naïve primary membranous nephropathy (PMN) patients Description of the study intervention Intervention group: rituximab combined with corticosteroids: 39 cases. Patients are pretreated with diphenhydramine and dexamethasone 30-60 minutes before rituximab infusion. * 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; \- Consolidation therapy after 6 months: Patients who achieve CR do not require consolidation therapy; Patients who had a 24-hour reduction in proteinuria \>25% but did not achieve CR received an additional course of rituximab 1g, D1, D15 (independent of CD19+ cell count). Patients with less than 25% decrease in proteinuria in 24 hours do not require continued medical therapy, and were considered as treatment failure and withdraw from the trial. Control group: Rituximab monotherapy: 39 cases, \- Treatment regimen: 30-60 minutes before intravenous infusion of rituximab, diphenhydramine 20mg intramuscularly and dexamethasone 5mg intravenously were given for pretreatment. * Induction therapy:Rituximab intravenous infusion of 1g, d1, d15 * Consolidation therapy after 6 months: Patients who achieve CR do not require consolidation therapy; Patients who had a 24-hour reduction in proteinuria \>25% but did not achieve CR received an additional course of rituximab 1g, D1, D15 (independent of CD19+ cell count). Patients with less than 25% decrease in proteinuria in 24 hours do not require continued medical therapy, and were considered as treatment failure and withdraw from the trial. The duration of the entire clinical study was 36 months from the date of project initiation. Duration of visits: 2 years

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-29
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2022-08-24
• Last updated: 2024-04-02

Locations

1 site across 1 country: China