Phase III Study of Atrasentan Treatment for Children Aged 2 to Under 18 With Primary IgA Nephropathy

What this Trial Is About

Researchers are evaluating atrasentan in children and adolescents aged 2 to under 18 years with primary immunoglobulin A nephropathy IgAN, a kidney condition. This Phase III, single-arm, multicenter study aims to assess the drugs effectiveness, how it is processed by the body, safety, and tolerability. The study addresses a need for treatments specifically studied in pediatric patients with biopsy-confirmed primary IgAN. Participants will receive atrasentan orally once daily at a fixed dose of 0.75 mg or a body-weight-adjusted dose for up to 104 weeks while continuing stable treatment with the maximum tolerated dose of a renin-angiotensin system inhibitor such as ACE inhibitors or ARBs as part of standard care. The study enrolls patients in cohorts based on body weight, starting with those weighing at least 40 kg to collect safety, tolerability, pharmacokinetics, and biomarker data. Patients completing the 104-week treatment and study may join an open-label extension to continue receiving the drug. During the study, participants will undergo regular assessments including measuring proteinuria changes from baseline to week 36, kidney function tests, pharmacokinetic evaluations, and monitoring of adverse events. Proteinuria is measured using urine protein-to-creatinine ratios from first morning void samples. Safety and drug levels will be reviewed throughout the trial by an independent data monitoring committee. The total study duration allows for close monitoring of atrasentans effects and participant health over two years or more.

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN