A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared with Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease (Stage 3b and 4)

Renal Insufficiency, Chronic

Time from randomization to first occurrence cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event, 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

Time from randomization to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR, Change from baseline in urinary albumin to creatinine ratio to Week 24, Change from baseline to Week 24 in urinary albumin to creatinine ratio, assessed from spot urine albumin and creatinine measurements, Time from randomization to first occurrence of cardiovascular death or heart failure event., Time 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., Time to death from any cause, Time from randomization to death from any cause., 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

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