A Prospective, Randomized, Multicenter Clinical Trial Comparing Rituximab Combined With Corticosteroids or Rituximab Monotherapy in Primary Membranous Nephropathy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two treatment approaches for patients with primary membranous nephropathy (PMN), a kidney condition. This prospective, randomized, multicenter clinical trial compares rituximab combined with corticosteroids against rituximab alone. The study aims to measure the complete response rate at 12 months and track other clinical outcomes over 24 months. The trial involves 78 adult patients with PMN who have not received prior treatment. Participants are randomly assigned to one of two groups: one receiving rituximab combined with oral prednisolone corticosteroids, and the other receiving rituximab monotherapy. Rituximab is given as two intravenous infusions (1 gram each) on days 1 and 15. In the combined group, prednisolone starts at 0.5 mg/kg daily and is gradually tapered over about a year. After 6 months, patients who show a significant but incomplete reduction in proteinuria receive additional rituximab doses. Those with insufficient improvement discontinue treatment and leave the trial. Participants are monitored for 2 years with regular visits to assess kidney function, proteinuria levels, immune markers such as CD19+ cell counts and anti-PLA2R antibodies, and safety outcomes. Researchers will evaluate response rates at multiple time points, remission duration, relapse rates, and cumulative steroid exposure. The study includes safety monitoring and ongoing evaluation of kidney function using estimated glomerular filtration rate (eGFR). The entire clinical study lasts 36 months from the start date, including follow-up assessments.

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