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Treatment of Primary Membranous Nephropathy with SNP-ACTH Gel

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

PHASE3 · Cerium Pharmaceuticals, Inc. · NCT05696613

This study is testing a new gel treatment for primary membranous nephropathy to see if it works better than an existing medication called rituximab.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment148 (estimated)
Ages18 Years and up
SexAll
SponsorCerium Pharmaceuticals, Inc. (industry)
Drugs / interventionsrituximab, cyclophosphamide
Locations31 sites (Los Angeles, California and 30 other locations)
Trial IDNCT05696613 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of SNP-ACTH (1-39) Gel compared to rituximab in patients with primary membranous nephropathy (PMN). It consists of two phases: the first phase focuses on determining the optimal dose of SNP-ACTH Gel through a dose-finding approach involving 16 patients, while the second phase will assess the efficacy of the selected dose in a larger group of 132 patients over 12 months. The trial is designed as an open-label, head-to-head comparison to provide insights into the treatment's potential benefits.

Who should consider this trial

Good fit: Ideal candidates include patients with biopsy-proven membranous glomerulonephritis and nephrotic syndrome who are at high risk for progressive kidney function loss.

Not a fit: Patients who do not have a confirmed diagnosis of membranous nephropathy or those who are not at high risk for kidney function loss may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from primary membranous nephropathy.

How similar studies have performed: Previous studies have shown promising results with similar approaches in treating kidney diseases, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Membranous Nephropathy, Kidney disease, Rituximab, Nephritis, Melanocortin, Hormones, Glucocorticoids, Glomerular Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.