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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06742723 | A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure | PHASE3 | RECRUITING | 5,000 | — | — | Mar 3, 2025 | Dec 18, 2029 | Jun 2, 2026 | 761 | United States, Argentina +40 |
| NCT06268873 | A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. | PHASE3 | ACTIVE NOT_RECRUITING | 2,554 | — | — | Mar 29, 2024 | Feb 24, 2028 | May 12, 2026 | 565 | United States, Argentina +36 |
| NCT07222917 | A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. | PHASE2 | RECRUITING | 218 | — | — | Dec 5, 2025 | May 24, 2027 | May 18, 2026 | 71 | United States, Argentina +9 |
Time to the first occurrence of any of the components of the composite of: Kidney disease progression * ≥ 50% sustained decline in eGFR * Onset of kidney failure: * Sustained eGFR \< 15 mL/min/1.73 m2 or * Chronic dialysis treatment or * Receiving a kidney transplant or * Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events * HF with or without hospitalisation * CV death
Change from baseline in eGFR to post treatment.
Change from baseline in UACR
| Arm | Type | Description |
|---|---|---|
| Baxdrostat/dapagliflozin | EXPERIMENTAL | Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. |
| Placebo/dapagliflozin | PLACEBO_COMPARATOR | Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily. |
| Dapagliflozin | ACTIVE_COMPARATOR | Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily |
| Baxdrostat /placebo | PLACEBO_COMPARATOR | Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily |
| Name | Type | Description |
|---|---|---|
| Baxdrostat/dapagliflozin | DRUG | baxdrostat tablet dapagliflozin tablet |
| Placebo/dapagliflozin | DRUG | dapagliflozin tablet placebo tablet |
| Dapagliflozin in combination with placebo | DRUG | dapagliflozin tablet placebo tablet |
| Baxdrostat/Placebo | DRUG | baxdrostat tablet placebo tablet |
Inclusion Criteria: 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent. 2. Participants with (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: * UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmo...