Phase 3Recruiting
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN (ADVANCE)
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)
- Sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 28 planned
- Conditions
- Berger Disease; Bergers Disease; IgA Nephropathy; Immunoglobulin A Nephropathy; Primary IgAN; Nephritis IgA Type, Nephropathy IgA Type
- Interventions
- Drug: Atrasentan
- Ages
- children, adults
- Registry
- NCT07498335
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Change From Baseline in Proteinuria at Week 36
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered