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

{ "A Study of SNP-ACTH (1-39) Gel for Primary Membranous Nephropathy", "This study is testing SNP-ACTH (1-39) Gel against Rituximab for people with primary membranous nephropathy (PMN), a kidney disease. The study aims to find the best dose of SNP-ACTH (1-39) Gel and then compare its effectiveness to Rituximab over 24 months. You may be able to join if you are 18 or older, have PMN confirmed by a biopsy or a positive anti-PLA2R antibody test, and are at high risk for kidney function loss. Success will be measured by changes in protein in your urine, levels of certain antibodies, and whether your PMN completely responds to treatment. The current recruitment status is unclear.", "design": "This study is an open-label, two-phase trial comparing SNP-ACTH (1-39) Gel to Rituximab. It will involve up to 148 participants who will be randomly assigned to different treatments.", "commitments": "In Phase 3a, you would receive SNP-ACTH (1-39) Gel injections three times per week for 12 months. In Phase 3b, you would receive either SNP-ACTH (1-39) Gel at the chosen dose for 12 months or Rituximab over two treatment cycles at month 1 and month 6.", "compensation": "Not stated in the trial record.", "follow_up": "Your progress will be measured at various times up to 12 months for changes in urine protein and antibody levels, and up to 24 months for complete response of PMN.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05696613

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Cerium Pharmaceuticals, Inc.
~148 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:SNP-ACTH (1-39) GelRituximab

At a glance

Recruiting sites
31 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in urinary protein (Phase 3a)
Measured over Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
+2 more outcomes measured
Primary Membranous Nephropathy
31 sites across 19 states
Florida6
California3
Georgia2
Texas2
Virginia2
Andhra Pradesh2
Rajasthan2
Illinois1

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Change in urinary protein (Phase 3a)Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
  • Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a)Change from baseline, months 1, 2, 3, 4, 6, and 12
  • Complete response of PMN (Phase 3b)24 months

    Reduction of proteinuria to ≤0.3 g/24 hours as measured by urine protein/creatinine ratio obtained from a 24-hour urine collection with stable renal function defined as a \<15% decline in eGFR at the time of endpoint assessment