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

Description

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.

Conditions

Primary Membranous Nephropathy

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Study Overview

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Study Details

Study overview

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.

A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel Compared to Rituximab and FDA Approved Biosimilars in Adults With Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design

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

Condition
Primary Membranous Nephropathy
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Academic Medical Research Institute, Los Angeles, California, United States, 90022

San Dimas

North America Research Institute, San Dimas, California, United States, 91773

Tarzana

Valiance Clinical Research, Tarzana, California, United States, 91356

Boynton Beach

RecioMed Clinical Research Network, Inc., Boynton Beach, Florida, United States, 33472

Coral Springs

South Florida Nephrology Research, Coral Springs, Florida, United States, 33071

Fort Lauderdale

Therafirst Medical Center, Fort Lauderdale, Florida, United States, 33308

Miami

Reliant Medical Research, LLC, Miami, Florida, United States, 33165

Miami

Vista Health Research, LLC, Miami, Florida, United States, 33176

Tampa

Genesis Clinical Research, Tampa, Florida, United States, 33603

Atlanta

Fides Clinical Research, Atlanta, Georgia, United States, 30342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cerium Pharmaceuticals, Inc.,

Study Record Dates

2026-03-01