What is the Purpose of this Study?
This study focuses on people who have been diagnosed with IgA nephropathy (IgAN), IgA vasculitis with nephritis (IgAVN), primary membranous nephropathy (pMN), or minimal change disease and focal segmental glomerular sclerosis (MCD and FSGS). IgA nephropathy (also known as Berger’s disease) is a condition that causes damage to the tiny filters (called glomeruli) inside the kidneys. IgA vasculitis with nephritis is a disease of the blood vessels and kidneys. Primary membranous nephropathy is a disease that causes the glomeruli inside the kidneys to leak protein. Minimal change disease and focal segmental glomerular sclerosis are a family of diseases in which the glomeruli of the kidney leak protein. The purpose of this study is to learn about the effectiveness of an experimental drug called atacicept on decreasing the damage to the kidneys. Atacicept is an immune modulator. Immune modulators are medicines that can change the body’s immune system and immune response. The study will also evaluate the safety of atacicept in patients with IgAN/IgAVN, pMN, or MCD/FSGS. During the study, participants’ IgA levels and kidney function will be checked; they will be given atacicept that is provided in a pre-filled syringe for a weekly shot.
Eligibility
- * Must have the ability to understand and sign a written informed consent form
- * Male or female of ≥18 years of age
- * Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
- * Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases