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Clinical Trials in India / NCT05696613
Recruiting Phase 3

A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy

NCT05696613 · tracked via the Priya Life Science India tracker
Sponsor
Cerium Pharmaceuticals, Inc.
Phase
Phase 3
Started
2023-03-13
Last updated
2026-06-25

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

SNP-ACTH (1-39) GelRituximab

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
Academic Medical Research Institute Los Angeles California Recruiting
North America Research Institute San Dimas California Recruiting
Valiance Clinical Research Tarzana California Recruiting
RecioMed Clinical Research Network, Inc. Boynton Beach Florida Recruiting
South Florida Nephrology Research Coral Springs Florida Recruiting
Therafirst Medical Center Fort Lauderdale Florida Recruiting
Reliant Medical Research, LLC Miami Florida Recruiting
Vista Health Research, LLC Miami Florida Recruiting
Genesis Clinical Research Tampa Florida Recruiting
Fides Clinical Research Atlanta Georgia Recruiting
Costal Medical Research Brunswick Georgia Recruiting
Insight Hospital and Medical Center Chicago Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
Center for Advanced Kidney Research, PLC Saint Clair Shores Michigan Recruiting
NYU Langone Health New York New York Recruiting
Prolato Clinical Research Center Houston Texas Recruiting
P&I Clinical Research LLC Lufkin Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
Nephrology Associates of Northern Virginia Fairfax Virginia Recruiting
Regional Kidney Wellness Centre Brampton Ontario Recruiting
Vedanta Hospitals Guntur Andhra Pradesh Recruiting
Vijaya Super Speciality Hospital Nellore Andhra Pradesh Recruiting
AIIMS Raipur Chhattisgarh Recruiting
Muljibhai Patel Urological Hospital Nadiād Gujarat Recruiting
KLE Hospital Belagavi Karnataka Recruiting
Saraswati Kidney Care Center Nagpur Maharashtra Recruiting
Sir Ganga Ram Hospital New Delhi National Capital Territory of Delhi Recruiting
PGIMER Chandigarh Punjab Recruiting
SMS Medical College and Hospital Jaipur Rajasthan Recruiting
Apex Hospitals Jaipur Rajasthan Recruiting
Galaxy Hospital Varanasi Uttar Pradesh Recruiting

On this site

📄 Rituxan (rituximab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05696613 on ClinicalTrials.gov ↗ ← All trials in India