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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04573478 | Atrasentan in Patients With IgA Nephropathy | PHASE3 | ACTIVE NOT_RECRUITING | 404 | — | — | Dec 11, 2020 | Apr 14, 2028 | Jun 4, 2026 | 135 | United States, Argentina +18 |
| NCT05834738 | Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy | PHASE2 | COMPLETED | 54 | — | — | Jul 20, 2023 | Oct 29, 2025 | Jan 30, 2026 | 30 | United States, Australia +4 |
| NCT04573920 | Atrasentan in Patients With Proteinuric Glomerular Diseases | PHASE2 | ACTIVE NOT_RECRUITING | 103 | — | — | Mar 15, 2021 | Oct 27, 2026 | Jun 1, 2026 | 33 | United States, Australia +4 |
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 36. (non-SGLT2i stratum)
Type, incidence, severity, seriousness, and relatedness of TEAEs.
Incidence, severity, seriousness, and relatedness AESIs.
Type, incidence, severity, seriousness, and relatedness of TEAEs
Incidence, severity, seriousness, and relatedness AESIs.
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12
The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24
| Arm | Type | Description |
|---|---|---|
| Atrasentan | EXPERIMENTAL | Double-blind Period: Once daily oral administration of 0.75 mg atrasentan for 132 weeks. Open-label Extension Period: Once daily oral administration of 0.75 mg atrasentan for 48 weeks after completion of 132 weeks on atrasentan or placebo. Substudy period: Once daily oral administration of 0.75 mg atrasentan + zigakibart for 48 weeks after completion of OL extension period |
| Placebo | PLACEBO_COMPARATOR | Double-blind Period: Once daily oral administration of placebo for 132 weeks |
| Sequence AB | EXPERIMENTAL | Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period A) followed by once daily oral administration of placebo for 24 weeks (Period B) |
| Sequence BA | EXPERIMENTAL | Once daily oral administration of placebo for 12 weeks (Period B) followed by once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period A) |
| Atrasentan 0.75 mg | EXPERIMENTAL | Once daily oral administration of 0.75 mg atrasentan |
| Atrasentan 1.5 mg | EXPERIMENTAL | Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only) |
| Name | Type | Description |
|---|---|---|
| Atrasentan | DRUG | Film-coated tablet |
| Placebo | DRUG | Film-coated tablet |
| Zigakibart | DRUG | pre-filled syringes with needle safety device |
Inclusion Criteria: Double-Blind period: * Biopsy-proven IgA nephropathy. * Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor th...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 11 | PHASE3 | BION-1301, LNP023, Atrasentan, Zigakibart, zigakibart |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Travere Therapeutics, Inc. | TVTX | 2 | PHASE3 | sparsentan, irbesartan, Dapagliflozin, Sparsentan |
| Biogen Inc. | BIIB | 1 | PHASE3 | Felzartamab |
| Vertex Pharmaceuticals Incorporated | VRTX | 2 | PHASE3 | Povetacicept |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Biohaven Ltd. | BHVN | 1 | PHASE1 | BHV-1400 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |