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.
Parallel
Balcinrenone/dapagliflozin
Drugbalcinrenone/dapagliflozin 15 mg/10 mg
Dapagliflozin
Drugdapagliflozin 10 mg
Placebo matching Dapagliflozin
Drugmatching placebo for dapagliflozin 10 mg
Placebo matching balcinrenone/dapagliflozin
Drugmatching placebo for balcinrenone/dapagliflozin
Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event
Time from randomization 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
Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.
Time from randomization 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
Change in urinary albumin to creatinine ratio to Week 24
Change from baseline to Week 24 in urinary albumin to creatinine ratio
Time to first occurrence of cardiovascular death or heart failure event.
Time from randomization to first occurrence of any of the components of the composite: * CV death * HF with or without hospitalisation
Time to cardiovascular death
Time from randomization to cardiovascular death.
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