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RecruitingPhase 3

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

Cerium Pharmaceuticals, Inc. · NCT05696613

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
148
US sites recruiting
19
Study start
March 13, 2023
Record last updated
June 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SNP-ACTH (1-39) Gel; Rituximab

Conditions: Primary Membranous Nephropathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Nancy Klett, MPH · 703-395-0629 · Nancy.Klett@ceriumpharma.com
A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous… (NCT05696613) | Bored Studies