A phase 2 open-label single-arm cohort study to evaluate the safety efficacy and pharmacokinetics of sparsentan treatment in pediatric subjects with selected proteinuric glomerular diseases (EPPIK)
Brief description of study
The purpose of this research study is to study if an investigational drug (one that is not FDA approved), named sparsentan, will help in the treatment of kidney diseases and if it is safe to use in people. Sparsentan is considered investigational because it is not Food and Drug Administration (FDA) approved to treat your kidney disease and is being tested in this research study. This is a multicenter, open-label, 108-week study of sparsentan in approximately 57 pediatric subjects with selected proteinuric glomerular diseases, divided into 2 populations, defined as follows: Population 1: Subjects with focal segmental glomerulosclerosis(FSGS) or minimal change disease (MCD).Population 2: Subjects with biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or subjects with Alport syndrome (AS) The study will evaluate long-term safety, tolerability, and efficacy with PK evaluations at Day 1 (Baseline), Day 2 (Visit 3), and Week 12.
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