NCT05696613 A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
| NCT ID | NCT05696613 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cerium Pharmaceuticals, Inc. |
| Condition | Primary Membranous Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 148 participants in total. It began in 2023-03-13 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05696613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Membranous Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05696613 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 148 participants.
Is NCT05696613 currently recruiting?
Yes, NCT05696613 is actively recruiting participants. Contact the research team at Nancy.Klett@ceriumpharma.com for enrollment information.
Where is the NCT05696613 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Dimas, United States, Tarzana, United States, Boynton Beach, United States and 11 additional locations.
Who is sponsoring the NCT05696613 clinical trial?
NCT05696613 is sponsored by Cerium Pharmaceuticals, Inc.. The trial plans to enroll 148 participants.