Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07498335 | Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN | PHASE3 | NOT YET_RECRUITING | 28 | — | — | Aug 26, 2026 | Dec 13, 2032 | Jun 1, 2026 | - | — |
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (≥40 kg of body weight) | EXPERIMENTAL | Once daily oral administration of 0.75 mg atrasentan for 104 weeks |
| Cohort 2 (30 to <40 kg of body weight) | EXPERIMENTAL | Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks |
| Cohort 3 (20 to <30 kg of body weight) | EXPERIMENTAL | Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks |
| Cohort 4 (10 to <20kg of body weight) | EXPERIMENTAL | Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks |
| Name | Type | Description |
|---|---|---|
| Drug: Atrasentan | DRUG | * 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627 |
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 fema...