RecruitingPhase 3NCT05696613

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

Sponsor

Cerium Pharmaceuticals, Inc.

Enrollment

148 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Primary Membranous Nephropathy

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called SNP-ACTH (1-39) Gel — a form of synthetic corticotropin — in patients with primary membranous nephropathy (MN), a kidney disease where the immune system attacks the filtering membranes of the kidneys. MN can cause massive protein leakage in the urine, swelling, and progressive kidney failure. This drug is being studied as an alternative to more toxic immunosuppressive regimens for patients at high risk of kidney function loss. You may be eligible if: - Your kidney biopsy confirms membranous glomerulonephritis, OR you have nephrotic syndrome with a positive anti-PLA2R antibody test - You are classified as high risk for kidney function loss (per KDIGO 2021 guidelines) - Your kidney filtration rate (eGFR) is at least 40 mL/min/1.73 m² - You have relapsed after responding to prior immunosuppressive therapy (at appropriate washout periods) - Your life expectancy is more than 24 months You may NOT be eligible if: - Your membranous nephropathy is caused by a secondary condition (infection, cancer, lupus, etc.) - Your PLA2R antibody levels have already dropped by 50% or more in the past year - You have Type 1 or Type 2 diabetes - You had surgery within the past month - You have a known sensitivity to porcine (pig-derived) proteins Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSNP-ACTH (1-39) Gel

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

DRUGRituximab

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

View Full Details on ClinicalTrials.gov

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NCT05696613

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