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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522824-29-00

Enrollment

Registered

2026-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary IgAN

Brief summary

Change in proteinuria (natural log UPCR* sampled from FMV urine collection) from Baseline to Week 36 (all cohorts combined)

Detailed description

Change in proteinuria (natural log UPCR* sampled from FMV urine collection) from Baseline to Week 36 (in participants with ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation, all cohorts combined), PK parameters Cmaxss, AUCss, CLss/F (and other PK parameters in plasma, as appropriate), and Ctrough concentrations., Safety endpoints (including AEs, SAEs, laboratory parameters, and vital signs)

Interventions

DRUGEXV811

DRUGatrasentan

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change in proteinuria (natural log UPCR* sampled from FMV urine collection) from Baseline to Week 36 (all cohorts combined)	—

Secondary

Measure	Time frame
Change in proteinuria (natural log UPCR* sampled from FMV urine collection) from Baseline to Week 36 (in participants with ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation, all cohorts combined), PK parameters Cmaxss, AUCss, CLss/F (and other PK parameters in plasma, as appropriate), and Ctrough concentrations., Safety endpoints (including AEs, SAEs, laboratory parameters, and vital signs)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 11, 2026