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.
This head-to-head, open-label, 2-phase superiority trial compares SNP-ACTH (1-39) Gel to rituximab in the treatment of PMN that commences with an adaptive trial design for dose finding. The trial will be divided into 2 parts: Phase 3a and Phase 3b. Dose finding Phase 3a part of the study will enroll a total of 16 patients randomized to 2 different dose levels of SNP-ACTH (1-39) Gel treatment for 12 months. Dose levels will be: * 8 patients at 3mg SNP-ACTH Gel subcutaneous (sc) injection 3 times per week; * 8 patients at 5mg SNP-ACTH Gel sc injection 3 times per week Data from the Phase 3a part of the study will be assessed at regular intervals (at months 2, 3, 4, 5, 6, 9, 12) and will inform the dose selection for the Phase 3b. The optimal dose will be determined based on a risk/benefit assessment from data obtained from the Phase 3a part of the study, with the earliest assessment being conducted after all patients have completed at least 2 months of therapy. The Phase 3b part of the study will enroll 132 patients randomized 1:1 to either 12 months of 1g Rituximab therapy (2 treatment cycles at month 1 and month 6) or 12 months of SNP-ACTH (1-39) Gel treatment at the dose level determined in the Phase 3a.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
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.
Change in urinary protein (Phase 3a)
Time frame: 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)
Time frame: 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
Time frame: 24 months
Relapse rate at month 12 and month 24.
Time frame: 12 and 24 months
Anti-PLA2R (or Anti-THSD7A) auto-antibody levels.
Time frame: 12 and 24 months
Estimated glomerular filtration rate (eGFR) with proteinuria levels.
Time frame: 12 and 24 months
Adverse events
Time frame: 24 months
Incidence of ADAs
Time frame: 24 months
Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12.
Time frame: 12 months
Number of patients who achieved a Immunological Response (IR) at month 12.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Academic Medical Research Institute
Los Angeles, California, United States
RECRUITINGNorth America Research Institute
San Dimas, California, United States
RECRUITINGValiance Clinical Research
Tarzana, California, United States
RECRUITINGRecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States
RECRUITINGSouth Florida Nephrology Research
Coral Springs, Florida, United States
RECRUITINGTherafirst Medical Center
Fort Lauderdale, Florida, United States
RECRUITINGReliant Medical Research, LLC
Miami, Florida, United States
RECRUITINGVista Health Research, LLC
Miami, Florida, United States
RECRUITINGGenesis Clinical Research
Tampa, Florida, United States
RECRUITINGFides Clinical Research
Atlanta, Georgia, United States
RECRUITING...and 21 more locations
Assessment of time to achieving CR, PR, IR.
Time frame: 24 months
Assessment of time to relapse for patients who achieved CR, PR, IR.
Time frame: 12 and 24 months
Duration of time between initial achievement of CR to latest date of observed remission.
Time frame: 24 months