Novartis Pharmaceuticals
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).
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…
Inclusion Criteria: 1. Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement. 2. Male and female participants 2 to \< 18 years of age as of Day 1. 3. eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period. 4. Kidney biopsy-proven primary IgAN\*, with biopsy performed within 3 years of Screening with \< 50% tubu…
* 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627