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
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDrug: Atrasentan
* 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627
Locations (2)
- University of Oklahoma Health Science CenterOklahoma City, Oklahoma
- University of Tennessee Health Science Center- Le Bonheur Research CenterMemphis, Tennessee