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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07624305 | A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD) | PHASE3 | NOT YET_RECRUITING | 2,800 | — | — | Sep 1, 2026 | Jul 1, 2030 | Jun 3, 2026 | 45 | Argentina, Canada +6 |
Time to first occurrence of any of the components of the composite: * CV death * Death from kidney failure * Onset of kidney failure * Initiation of maintenance dialysis or * Kidney transplantation * Sustained ≥ 50% decline from baseline in eGFR * HF with or without hospitalisation
| Arm | Type | Description |
|---|---|---|
| Balcinrenone/dapagliflozin | EXPERIMENTAL | Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin. |
| Dapagliflozin | ACTIVE_COMPARATOR | Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg. |
| Name | Type | Description |
|---|---|---|
| Balcinrenone/dapagliflozin | DRUG | balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg |
| Dapagliflozin | DRUG | dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin |
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of CKD and at least one of the following: 1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory). 2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \...