Phase 3 Study Comparing Felzartamab Infusions to Oral Tacrolimus in Adults With Primary Membranous Nephropathy

What this Trial Is About

Researchers are studying primary membranous nephropathy PMN, a kidney condition where harmful autoantibodies build up in the kidney filters, causing damage. This can lead to protein and blood leaking into the urine, swelling, tiredness, and high blood pressure. The study aims to compare how the laboratory-made antibody drug felzartamab works compared to the existing drug tacrolimus in treating PMN, focusing on how many participants achieve complete remission over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus as oral tablets. Those whose disease worsens or who do not improve may receive additional rescue treatment, including standard immunosuppressive therapy or felzartamab. The study includes an open-label treatment phase and a non-responder treatment phase for those needing rescue therapy. Participants will undergo up to 23 study visits during screening and treatment, which may last up to 104 weeks or 156 weeks if rescue treatment is needed. Researchers will monitor urine protein levels, kidney function, antibody levels, physical health, and side effects. Follow-up visits every 12 weeks will continue if treatment stops early to assess long-term effects and safety.

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)