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

RecruitingPhase 3Ages 18 Years - anyAllCerium Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ40 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 โ‰ฅ 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.
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What it tests

  • SNP-ACTH (1-39) Gel
  • Rituximab
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Where

31 sites
Academic Medical Research Institute
Los Angeles, United States
North America Research Institute
San Dimas, United States
Valiance Clinical Research
Tarzana, United States
RecioMed Clinical Research Network, Inc.
Boynton Beach, United States
South Florida Nephrology Research
Coral Springs, United States
Therafirst Medical Center
Fort Lauderdale, United States
Reliant Medical Research, LLC
Miami, United States
Vista Health Research, LLC
Miami, United States

โ€ฆand 23 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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