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New treatment option for Primary Membranous Nephropathy
Official title A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
ClinicalTrials.gov ID: NCT05696613
What this study is testing
What is SNP-ACTH (1-39) Gel?
SNP-ACTH (1-39) Gel is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for primary membranous nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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 may apply.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Dimas, California, United States
- Tarzana, California, United States
- Boynton Beach, Florida, United States
- Coral Springs, Florida, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Brunswick, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Saint Clair Shores, Michigan, United States
- New York, New York, United States
- Houston, Texas, United States
- Lufkin, Texas, United States
- Charlottesville, Virginia, United States
- Fairfax, Virginia, United States
- Brampton, Ontario, Canada
- Guntur, Andhra Pradesh, India
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Dimas, California, United States; Tarzana, California, United States; Boynton Beach, Florida, United States; Coral Springs, Florida, United States; Fort Lauderdale, Florida, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.