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.
Age ≥ 18 years
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).
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
Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.
SBP > 180 mmHg or DBP > 110 mmHg at screening.
SBP < 90 mmHg at screening.