Phase 2 Study of Sparsentan Treatment for Children Aged 1 to 17 With Selected Proteinuric Kidney Diseases

What this Trial Is About

The trial investigates the safety, effectiveness, and tolerability of sparsentan in children aged 1 to under 18 years old who have specific proteinuric glomerular diseases, including Focal Segmental Glomerulosclerosis FSGS, Minimal Change Disease MCD, Immunoglobulin A Nephropathy IgAN, IgA Vasculitis IgAV, and Alport Syndrome AS. The study is a phase 2, open-label, multicenter trial involving approximately 67 pediatric participants divided into three populations based on diagnosis and age groups. Participants receive sparsentan either as an oral suspension or tablets depending on their population group and age. Population 1 receives 800 mg sparsentan oral suspension, Population 2 receives 400 mg sparsentan oral suspension, and Population 3 receives 400 mg sparsentan tablets. The study spans 112 weeks, with pharmacokinetic evaluations at various time points specific to each population. The trial includes multiple cohorts based on age ranges within each population. During the study, participants will have regular visits for safety and efficacy assessments, including monitoring of adverse events and changes in proteinuria measured by urine proteincreatinine ratio. Pharmacokinetic samples are collected at scheduled visits. Other measures include urine albumincreatinine ratio, estimated glomerular filtration rate, and remission status of proteinuria. The total participation time is approximately 108 weeks after the last patient visit, with ongoing safety monitoring and evaluations throughout the study period.

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases