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)
Novartis Pharmaceuticals
Summary
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \<18 years with primary immunoglobulin A nephropathy (IgAN).
Description
This Phase III study aims to address the unmet medical need in pediatric primary IgAN by assessing the efficacy, pharmacokinetics, safety, and tolerability of atrasentan in patients aged 2 to \<18 years. Pediatric patients with biopsy-confirmed IgAN will receive atrasentan (0.75 mg or a body-weight-adjusted dose) for up to 104 weeks while taking the maximally tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor \[such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)\] as part of standard of care, if possible. The primary objective o…
Eligibility
- Age range
- 2–18 years
- Sex