RECRUITING

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

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Conditions

Primary Membranous NephropathyKidney diseaseRituximabNephritisMelanocortinHormonesGlucocorticoidsGlomerular DiseaseACTHPMN

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-13
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05696613

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test.
  2. * 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.
  3. * eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2
  4. * 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
  5. * 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
  6. * 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.
  7. * Life expectancy \> 24 months.
  8. * Other inclusion criteria may apply.
  1. * Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results or serologies.
  2. * Patients who have had a ≥ 50% reduction in serum titers of PLA2R auto-antibody within 1 year before screening.
  3. * Type 1 or 2 diabetes mellitus
  4. * Patients who must be initiated on drugs likely to affect renal function if not properly dosed.
  5. * Surgery within 1 month of study entry
  6. * History of sensitivity to proteins of porcine origin.
  7. * Other exclusion criteria may apply.

Contacts and Locations

Study Contact

Nancy Klett, MPH
CONTACT
703-395-0629
Nancy.Klett@ceriumpharma.com

Study Locations (Sites)

Academic Medical Research Institute
Los Angeles, California, 90022
United States
North America Research Institute
San Dimas, California, 91773
United States
Valiance Clinical Research
Tarzana, California, 91356
United States
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, 33472
United States
South Florida Nephrology Research
Coral Springs, Florida, 33071
United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
United States
Reliant Medical Research, LLC
Miami, Florida, 33165
United States
Vista Health Research, LLC
Miami, Florida, 33176
United States
Genesis Clinical Research
Tampa, Florida, 33603
United States
Fides Clinical Research
Atlanta, Georgia, 30342
United States
Costal Medical Research
Brunswick, Georgia, 31520
United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60615
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, 48080
United States
NYU Langone Health
New York, New York, 10016
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States
P&I Clinical Research LLC
Lufkin, Texas, 75904
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, 22033
United States

Collaborators and Investigators

Sponsor: Cerium Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2023-03-13
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Kidney disease
  • Rituximab
  • Nephritis
  • Melanocortin
  • Hormones
  • Glucocorticoids
  • Glomerular Disease
  • ACTH
  • PMN

Additional Relevant MeSH Terms

  • Primary Membranous Nephropathy