Treatment of Primary Membranous Nephropathy with SNP-ACTH Gel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Academic Medical Research Institute
  Los Angeles, California, United States Recruiting
• North America Research Institute
  San Dimas, California, United States Recruiting
• Valiance Clinical Research
  Tarzana, California, United States Recruiting
• RecioMed Clinical Research Network, Inc.
  Boynton Beach, Florida, United States Recruiting
• South Florida Nephrology Research
  Coral Springs, Florida, United States Recruiting
• Therafirst Medical Center
  Fort Lauderdale, Florida, United States Recruiting

Study contacts

• Study coordinator: Nancy Klett, MPH
• Email: Nancy.Klett@ceriumpharma.com
• Phone: 703-395-0629

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.