Travere Therapeutics, Inc.
To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
This is a multicenter, open-label, 112-week study of sparsentan in approximately 67 pediatric subjects aged ≥1 year to \<18 years with selected proteinuric glomerular diseases, divided into 3 populations, defined as follows: * Population 1: Subjects with selected proteinuric glomerular diseases associated with Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD) histological patterns * Population 2: Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or Alport syndrome (AS) * Population 3: Subjects with kidney bi…
Inclusion Criteria for All Subjects (All Three Populations): A subject must meet all of the following criteria to be eligible for participation in this study: * The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent/assent, and where required, the subject is willing to provide assent before any screening procedures per local requirements. * The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening. * The subject has a mean seated blood pressure between the 5th and 95th percentile for sex and height. I…
Population 1: 800 mg Sparsentan (oral suspension)
Population 2: 400 mg Sparsentan (oral suspension)
Population 3: 400 mg Sparsentan (tablets)