A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel Compared to Rituximab and FDA Approved Biosimilars in Adults With Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design
1 other identifier
interventional
148
3 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2023
Typical duration for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedApril 25, 2024
April 1, 2024
2 years
December 29, 2022
April 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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
24 months
Secondary Outcomes (10)
Relapse rate at month 12 and month 24.
12 and 24 months
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
12 and 24 months
Estimated glomerular filtration rate (eGFR) with proteinuria levels.
12 and 24 months
Adverse events
24 months
Incidence of ADAs
24 months
- +5 more secondary outcomes
Study Arms (4)
Phase 3a Cohort 1
EXPERIMENTAL3 mg SNP-ACTH Gel sc injection 3 times per week
Phase 3a Cohort 2
EXPERIMENTAL5 mg SNP-ACTH Gel sc injection 3 times per week
Phase 3b Cohort 1
EXPERIMENTALDose level to be confirmed once Phase 3a part is completed
Phase 3b Cohort 2
ACTIVE COMPARATORRituximab arm: Patients randomized to the rituximab arm will receive 1 g IV infusion on T0 (after baseline measures are collected) and day 15. A second course of rituximab 1g IV infusion will be administered 6 months after the first rituximab infusion and an additional 1 g IV infusion 14 days following the first 6-month infusion.
Interventions
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Eligibility Criteria
You may qualify 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) 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.
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Academic Medical Research Institute
Los Angeles, California, 90022, United States
North America Research Institute
San Dimas, California, 91773, United States
Valiance Clinical Research
Tarzana, California, 91356, United States
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, 33472, United States
South Florida Nephrology Research
Coral Springs, Florida, 33071, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
Reliant Medical Research, LLC
Miami, Florida, 33165, United States
Vista Health Research, LLC
Miami, Florida, 33176, United States
Genesis Clinical Research
Tampa, Florida, 33603, United States
Fides Clinical Research
Atlanta, Georgia, 30342, United States
Costal Medical Research
Brunswick, Georgia, 31520, United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60615, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, 48080, United States
NYU Langone Health
New York, New York, 10016, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
P&I Clinical Research LLC
Lufkin, Texas, 75904, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, 22033, United States
Regional Kidney Wellness Centre
Brampton, Ontario, L6T 0H9, Canada
Vedanta Hospitals
Guntur, Andhra Pradesh, 522001, India
Vijaya Super Speciality Hospital
Nellore, Andhra Pradesh, 524001, India
AIIMS
Raipur, Chhattisgarh, 492099, India
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
KLE Hospital
Belagavi, Karnataka, 590010, India
Saraswati Kidney Care Center
Nagpur, Maharashtra, 440015, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 10060, India
PGIMER
Chandigarh, Punjab, 160012, India
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004, India
Apex Hospitals
Jaipur, Rajasthan, 302017, India
Galaxy Hospital
Varanasi, Uttar Pradesh, 221010, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2022
First Posted
January 25, 2023
Study Start
March 13, 2023
Primary Completion
March 1, 2025
Study Completion
March 1, 2026
Last Updated
April 25, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share