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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Cerium Pharmaceuticals, Inc. · Participants: 148 · Started: Mar 13, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05696613

Locations in the U.S.

CaliforniaAcademic Medical Research Institute, Los Angeles
North America Research Institute, San Dimas
Valiance Clinical Research, Tarzana
FloridaRecioMed Clinical Research Network, Inc., Boynton Beach
South Florida Nephrology Research, Coral Springs
Therafirst Medical Center, Fort Lauderdale
Reliant Medical Research, LLC, Miami
Vista Health Research, LLC, Miami
Genesis Clinical Research, Tampa
GeorgiaFides Clinical Research, Atlanta
Costal Medical Research, Brunswick
IllinoisInsight Hospital and Medical Center Chicago, Chicago
IowaUniversity of Iowa, Iowa City
MichiganCenter for Advanced Kidney Research, PLC, Saint Clair Shores
New YorkNYU Langone Health, New York
TexasProlato Clinical Research Center, Houston
P&I Clinical Research LLC, Lufkin
VirginiaUniversity of Virginia, Charlottesville
Nephrology Associates of Northern Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.