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A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
Sponsor: Cerium Pharmaceuticals, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2023-03-13
Completion Date
2026-03-01
Last Updated
2024-04-25
Healthy Volunteers
No
Conditions
Interventions
SNP-ACTH (1-39) Gel
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Rituximab
Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
Locations (31)
Academic Medical Research Institute
Los Angeles, California, United States
North America Research Institute
San Dimas, California, United States
Valiance Clinical Research
Tarzana, California, United States
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States
South Florida Nephrology Research
Coral Springs, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Reliant Medical Research, LLC
Miami, Florida, United States
Vista Health Research, LLC
Miami, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Fides Clinical Research
Atlanta, Georgia, United States
Costal Medical Research
Brunswick, Georgia, United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, United States
NYU Langone Health
New York, New York, United States
Prolato Clinical Research Center
Houston, Texas, United States
P&I Clinical Research LLC
Lufkin, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, United States
Regional Kidney Wellness Centre
Brampton, Ontario, Canada
Vedanta Hospitals
Guntur, Andhra Pradesh, India
Vijaya Super Speciality Hospital
Nellore, Andhra Pradesh, India
AIIMS
Raipur, Chhattisgarh, India
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
KLE Hospital
Belagavi, Karnataka, India
Saraswati Kidney Care Center
Nagpur, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
PGIMER
Chandigarh, Punjab, India
SMS Medical College and Hospital
Jaipur, Rajasthan, India
Apex Hospitals
Jaipur, Rajasthan, India
Galaxy Hospital
Varanasi, Uttar Pradesh, India