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

ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCerium Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 m²

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SNP-ACTH (1-39) Gel

    Drug

    Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.

  • Rituximab

    Drug

    Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.

Treatment groups

148 Participants
are divided into 4 treatment groups
Group A: Phase 3a Cohort 1Experimental treatment 1 intervention
Group B: Phase 3a Cohort 2Experimental treatment 1 intervention
Group C: Phase 3b Cohort 1Experimental treatment 1 intervention
Group D: Phase 3b Cohort 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in urinary protein (Phase 3a)

Time frame
Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12
2

Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a)

Time frame
Change from baseline, months 1, 2, 3, 4, 6, and 12
3

Complete response of PMN (Phase 3b)

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

Time frame
24 months

Secondary outcomes

1

Relapse rate at month 12 and month 24.

Time frame
12 and 24 months
2

Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.

Time frame
12 and 24 months
3

Estimated glomerular filtration rate (eGFR) with proteinuria levels.

Time frame
12 and 24 months
4

Adverse events

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cerium Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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