A single-arm, multicenter, phase III study to assess efficacy, pharmacokinetics, safety and tolerability of atrasentan in pediatric patients of 2 to <18 years of age with primary immunoglobulin A nephropathy (IgAN)

Condition studied

Primary IgAN

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in proteinuria (natural log UPCR* sampled from FMV urine collection) from Baseline to Week 36 (all cohorts combined)

Endpoint detail

Change in proteinuria (natural log UPCR* sampled from FMV urine collection) from Baseline to Week 36 (in participants with ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation, all cohorts combined), PK parameters Cmaxss, AUCss, CLss/F (and other PK parameters in plasma, as appropriate), and Ctrough concentrations., Safety endpoints (including AEs, SAEs, laboratory parameters, and vital signs)