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

RecruitingPhase 3

Sponsor: Cerium Pharmaceuticals, Inc.

Conditions: Primary Membranous Nephropathy

Interventions: SNP-ACTH (1-39) Gel, Rituximab

Countries: United States, Canada, India

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (31)

Los Angeles, California, United States
San Dimas, California, United States
Tarzana, California, United States
Boynton Beach, Florida, United States
Coral Springs, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Brunswick, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Saint Clair Shores, Michigan, United States
New York, New York, United States
Houston, Texas, United States
Lufkin, Texas, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Brampton, Ontario, Canada
Guntur, Andhra Pradesh, India
Nellore, Andhra Pradesh, India
Raipur, Chhattisgarh, India
Nadiād, Gujarat, India
Belagavi, Karnataka, India
Nagpur, Maharashtra, India
New Delhi, National Capital Territory of Delhi, India
Chandigarh, Punjab, India
Jaipur, Rajasthan, India
Jaipur, Rajasthan, India
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