Phase 3 Trial Comparing SNP-ACTH 1-39 Gel to Rituximab in Adults with Primary Membranous Nephropathy Using an Adaptive Dose-Finding Design

What this Trial Is About

Researchers are evaluating the use of SNP-ACTH 1-39 Gel compared to rituximab for treating adults with primary membranous nephropathy PMN, a kidney condition. This trial uses a two-phase adaptive design to find the best dose of SNP-ACTH Gel and then assess its effectiveness against rituximab. The study is divided into Phase 3a for dose finding and Phase 3b for comparing treatments over 24 months. In Phase 3a, up to 24 patients will be randomly assigned to receive either 3 mg or 5 mg of SNP-ACTH Gel by subcutaneous injection three times a week for 12 months. Data from this phase will guide dose selection for Phase 3b. In Phase 3b, 132 patients will be randomized to receive either the selected dose of SNP-ACTH Gel for 12 months or rituximab infusions given in two cycles, one at the start and one at six months. Participants will be monitored throughout the study with regular assessments of urinary protein and auto-antibody levels during Phase 3a, and clinical responses at 24 months in Phase 3b. Researchers will track kidney function, relapse rates, immune responses, and safety outcomes. Study visits and evaluations will occur at multiple time points up to two years, supporting detailed understanding of treatment effects and patient health over time.

A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy