Primary Membranous Nephropathy Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Regional Kidney Wellness Centre | Brampton | Ontario |
India | KLE Hospital | Belgaum | Karnataka |
India | PGIMER | Chandigarh | Punjab |
India | Vedanta Hospitals | Guntur | Andhra Pradesh |
India | Apex Hospitals | Jaipur | Rajasthan |
India | SMS Medical College and Hospital | Jaipur | Rajasthan |
India | Muljibhai Patel Urological Hospital | Nadiad | Gujarat |
India | Saraswati Kidney Care Center | Nagpur | Maharashtra |
India | Vijaya Super Speciality Hospital | Nellore | Andhra Pradesh |
India | Sir Ganga Ram Hospital | New Delhi | Delhi |
India | AIIMS | Raipur | Chhattisgarh |
India | Galaxy Hospital | Varanasi | Uttar Pradesh |
United States | Fides Clinical Research | Atlanta | Georgia |
United States | RecioMed Clinical Research Network, Inc. | Boynton Beach | Florida |
United States | Costal Medical Research | Brunswick | Georgia |
United States | University of Virginia | Charlottesville | Virginia |
United States | Insight Hospital and Medical Center Chicago | Chicago | Illinois |
United States | South Florida Nephrology Research | Coral Springs | Florida |
United States | Nephrology Associates of Northern Virginia | Fairfax | Virginia |
United States | Therafirst Medical Center | Fort Lauderdale | Florida |
United States | Prolato Clinical Research Center | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | Academic Medical Research Institute | Los Angeles | California |
United States | P&I Clinical Research LLC | Lufkin | Texas |
United States | Reliant Medical Research, LLC | Miami | Florida |
United States | Vista Health Research, LLC | Miami | Florida |
United States | NYU Langone Health | New York | New York |
United States | Center for Advanced Kidney Research, PLC | Saint Clair Shores | Michigan |
United States | North America Research Institute | San Dimas | California |
United States | Genesis Clinical Research | Tampa | Florida |
United States | Valiance Clinical Research | Tarzana | California |
Lead Sponsor | Collaborator |
---|---|
Cerium Pharmaceuticals, Inc. |
United States, Canada, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in urinary protein (Phase 3a) | Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12 | ||
Primary | Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a) | Change from baseline, months 1, 2, 3, 4, 6, and 12 | ||
Primary | 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 | Relapse rate at month 12 and month 24. | 12 and 24 months | ||
Secondary | Anti-PLA2R (or Anti-THSD7A) auto-antibody levels. | 12 and 24 months | ||
Secondary | Estimated glomerular filtration rate (eGFR) with proteinuria levels. | 12 and 24 months | ||
Secondary | Adverse events | 24 months | ||
Secondary | Incidence of ADAs | 24 months | ||
Secondary | Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12. | 12 months | ||
Secondary | Number of patients who achieved a Immunological Response (IR) at month 12. | 12 months | ||
Secondary | Assessment of time to achieving CR, PR, IR. | 24 months | ||
Secondary | Assessment of time to relapse for patients who achieved CR, PR, IR. | 12 and 24 months | ||
Secondary | Duration of time between initial achievement of CR to latest date of observed remission. | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05800873 -
Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
|
Phase 1 | |
Recruiting |
NCT05514015 -
Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy
|
Phase 4 | |
Recruiting |
NCT05668403 -
A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy
|
Phase 1 | |
Active, not recruiting |
NCT04629248 -
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
|
Phase 3 | |
Recruiting |
NCT05862233 -
A Clinical Study of MIL62 in Primary Membranous Nephropathy
|
Phase 3 | |
Not yet recruiting |
NCT06466135 -
Study of WAL0921 in Patients With Glomerular Kidney Diseases
|
Phase 2 | |
Not yet recruiting |
NCT06120673 -
REmission in Membranous Nephropathy International Trial (REMIT)
|
Phase 3 | |
Recruiting |
NCT05398653 -
A Clinical Study of MIL62 in Primary Membranous Nephropathy
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05136456 -
Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
|
Phase 2 | |
Recruiting |
NCT05707377 -
A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy
|
Phase 2/Phase 3 |