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Recruiting Phase 3 NCT05696613

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

Trial Parameters

Condition Primary Membranous Nephropathy
Sponsor Cerium Pharmaceuticals, Inc.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 148
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-13
Completion 2025-03-01
Interventions
SNP-ACTH (1-39) GelRituximab

Brief Summary

The goal of the Phase 3a part of this clinical trial is to determine the optimal dose that will be used in the Phase 3b part of this clinical trial. The goal of the Phase 3b part is to assess the efficacy of SNP-ACTH (1-39) Gel relative to rituximab in patients with primary membranous nephropathy (PMN) at month 24.

Eligibility Criteria

Inclusion Criteria: * Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test. * Patients classified to be at a High Risk for progressive loss of kidney function, as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular Diseases Guideline. * eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2 * Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 3 months since their last dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolate mofetil * Patients who have had CR or PR in response to IS therapy, but then relapsed can participate in the study if it has been more than 6 months since their last dose of chlorambucil or cyclophosphamide * Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can pa

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