AstraZeneca
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.
This is a Phase III, multicentre, randomised, double-blind, double-dummy, parallel-group, active-controlled, event-driven study in participants with CKD Stage 3b and 4. The purpose of this study is to determine if balcinrenone/dapagliflozin, compared with dapagliflozin, administered as a capsule once daily on a background of standard of care (SoC) therapy, reduces the risk of CV death, death from kidney failure, kidney failure, sustained ≥ 50% decline from baseline in eGFR, and HF events in adults with CKD Stage 3b and 4. The study will also assess safety and tolerability of balcinrenone/dapa…
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 \< 30 mg/g (local or central laboratory UACR value). * Serum/plasma K+ ≤ 5.0 mmol/L * Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening. Exclusion Criteria: * Recent (within 90 days prior to screenin…
balcinrenone/dapagliflozin 15 mg/10 mg
dapagliflozin 10 mg
matching placebo for dapagliflozin 10 mg
matching placebo for balcinrenone/dapagliflozin