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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06087835 | Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria) | PHASE3 | ACTIVE NOT_RECRUITING | 1,835 | — | — | Nov 7, 2023 | Feb 18, 2027 | May 15, 2026 | 296 | United States, Argentina +28 |
| NCT06942910 | A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria | PHASE2 | RECRUITING | 224 | — | — | May 7, 2025 | Jul 31, 2026 | Apr 17, 2026 | 15 | Russia |
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function
To estimate the efficacy of zibotentan and dapagliflozin in FDC versus dapagliflozin alone in reducing albuminuria
| Arm | Type | Description |
|---|---|---|
| Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B | EXPERIMENTAL | Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination. |
| Dapagliflozin alone | ACTIVE_COMPARATOR | Participants will receive daily oral dose of dapagliflozin. |
| Name | Type | Description |
|---|---|---|
| Zibotentan/Dapagliflozin | DRUG | Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to |
| Dapagliflozin | DRUG | Participants will receive dapagliflozin as per the arms they are randomized to |
Inclusion Criteria: 1. Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. 2. Diagnosis of CKD, defined as eGFR ≥ 20 and \< 90 mL/min/1.73 m2 and UACR \> 700 mg/g (\> 79 mg/mmol) or UP...