Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)] . FDA label
Also known as CHK-01, ABT-627
Atrasentan · 4 trials · 10 indications
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36
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.
Change in proteinuria from Baseline to Week 12 across both periods between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
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 |
|---|---|---|
| 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 |
| 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 Atrasentan/Placebo | 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 Placebo/Atrasentan | 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 |
|---|---|---|
| Drug: Atrasentan | DRUG | * 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627 |
| Atrasentan | DRUG | Film-coated tablet |
| Placebo | DRUG | Film-coated tablet |
| Zigakibart | DRUG | pre-filled syringes with needle safety device |
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...
Atrasentan is an investigational small molecule being studied for IgA nephropathy, also called Berger disease, and other proteinuric glomerular diseases. It is in Phase 3 clinical development for IgA nephropathy, a kidney condition in which immunoglobulin A deposits cause inflammation and protein in the urine.
Atrasentan targets EDNRA, the endothelin receptor type A, and acts as an antagonist. By blocking this receptor, atrasentan is designed to reduce endothelin-mediated effects in the kidney. Endothelin receptor antagonism is being explored as an approach to lower proteinuria in glomerular diseases such as IgA nephropathy.
Atrasentan is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating atrasentan in IgA nephropathy and other proteinuric glomerular diseases.
Atrasentan is in Phase 3 clinical development and is investigational. It has not been established as approved for any indication. The Phase 3 program includes a pediatric study in primary IgA nephropathy and a Phase 3 study in adults with IgA nephropathy.
Atrasentan trials include NCT04573478, a Phase 3 study in adults with IgA nephropathy, and NCT07498335, a Phase 3 pediatric study in primary IgA nephropathy. Earlier studies include NCT05834738, a completed Phase 2 crossover trial, and NCT04573920, a Phase 2 trial in proteinuric glomerular diseases.
Yes, atrasentan is also referred to as Drug: Atrasentan. Both names refer to the same investigational small molecule developed by Novartis AG for IgA nephropathy and related kidney diseases.