The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.
The study will assess the safety and efficacy of atacicept in multiple autoimmune glomerular diseases including IgAN (IgA Nephropathy), pMN (Primary Membranous Nephropathy) and MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis) in participants ages 10 and above with weekly SC injections.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Atacicept 150 mg SC QW via pre-filled syringe
Vera Therapeutics
Brisbane, California, United States
RECRUITINGAE profile and results of routine clinical and laboratory tests
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs
Time frame: Baseline until end of study: 52 + 26 Weeks
Percent reduction in urine protein to creatinine ratio (UPCR)
Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36
Time frame: Baseline, Week 36
Changes from baseline estimated glomerular filtration rate (eGFR).
Changes from baseline in estimated glomerular filtration rate (eGFR).
Time frame: Baseline, Week 36, Week 52
Change in disease-specific antibodies
IgAN: Percent change from baseline galactose-deficient IgA1 (GdIgA1) levels at 36 and 52 weeks. pMN: Percent change from baseline in anti-PLA2R antibody levels at 4, 8, 12, 36, and 52 weeks. MCD/FSGS: Percent change from baseline anti-nephrin antibody levels at 4, 8, 12, 36, and 52 weeks (exploratory).
Time frame: Baseline through 52 Weeks
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