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

Launched by CERIUM PHARMACEUTICALS, INC. · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called SNP-ACTH (1-39) Gel for patients with a kidney condition known as Primary Membranous Nephropathy (PMN). The trial is divided into two parts: the first part aims to find the best dose of the gel, while the second part will compare its effectiveness to a standard treatment called rituximab over a period of 24 months. The study is currently recruiting participants and is open to people aged 65 and older, regardless of gender.

To be eligible for this trial, participants must have a confirmed diagnosis of PMN and be at high risk for losing kidney function. They should also have a specific kidney function measurement (eGFR) of at least 40, and they must have experienced a partial or complete response to previous immunosuppressive treatments but have since relapsed. There are some exclusions, such as having other types of kidney disease or certain health conditions like diabetes. Participants in this trial can expect to receive careful monitoring and support while they take part in the study, contributing to important research that could help improve treatment options for PMN.

Gender

ALL

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 participate in the study if it has been more than 12 months since their last dose of rituximab.
• • Life expectancy \> 24 months.
• • Other inclusion criteria may apply.
• Exclusion Criteria:
• • Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results or serologies.
• • Patients who have had a ≥ 50% reduction in serum titers of PLA2R auto-antibody within 1 year before screening.
• • Type 1 or 2 diabetes mellitus
• • Patients who must be initiated on drugs likely to affect renal function if not properly dosed.
• • Surgery within 1 month of study entry
• • History of sensitivity to proteins of porcine origin.
• • Other exclusion criteria may apply.