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

Recruiting now · Phase 3

Conditions studied: Primary Membranous Nephropathy

In brief

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.

Key facts

Study ID

NCT05696613

Run by

Cerium Pharmaceuticals, Inc.

People needed

148

Starts

2023-03-13

Expected to finish

2027-12-31

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Academic Medical Research Institute — Los Angeles, California, United States (enrolling)
• North America Research Institute — San Dimas, California, United States (enrolling)
• Valiance Clinical Research — Tarzana, California, United States (enrolling)
• RecioMed Clinical Research Network, Inc. — Boynton Beach, Florida, United States (enrolling)
• South Florida Nephrology Research — Coral Springs, Florida, United States (enrolling)
• Therafirst Medical Center — Fort Lauderdale, Florida, United States (enrolling)
• Reliant Medical Research, LLC — Miami, Florida, United States (enrolling)
• Vista Health Research, LLC — Miami, Florida, United States (enrolling)
• Genesis Clinical Research — Tampa, Florida, United States (enrolling)
• Fides Clinical Research — Atlanta, Georgia, United States (enrolling)
• Costal Medical Research — Brunswick, Georgia, United States (enrolling)
• Insight Hospital and Medical Center Chicago — Chicago, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Center for Advanced Kidney Research, PLC — Saint Clair Shores, Michigan, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Prolato Clinical Research Center — Houston, Texas, United States (enrolling)
• P&I Clinical Research LLC — Lufkin, Texas, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Nephrology Associates of Northern Virginia — Fairfax, Virginia, United States (enrolling)
• Regional Kidney Wellness Centre — Brampton, Ontario, Canada (enrolling)
• Vedanta Hospitals — Guntur, Andhra Pradesh, India (enrolling)
• Vijaya Super Speciality Hospital — Nellore, Andhra Pradesh, India (enrolling)
• AIIMS — Raipur, Chhattisgarh, India (enrolling)
• Muljibhai Patel Urological Hospital — Nadiād, Gujarat, India (enrolling)
• KLE Hospital — Belagavi, Karnataka, India (enrolling)

Full record on ClinicalTrials.gov

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