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/dapagliflozin. Eligible patients will randomly be assigned with a 1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study will be conducted at approximately 550 sites in approximately 30 countries, globally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,800
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
Time from randomization to first occurrence of 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 frame: Up to 46 months.
Time from randomization to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.
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
Time frame: Up to 46 months.
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 frame: Baseline to Week 24
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 frame: Up to 46 months.
Time from randomization to cardiovascular death
Time from randomization to cardiovascular death.
Time frame: Up to 46 months.
Time from randomization to death from any cause
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Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Halifax, Canada
Research Site
Magdeburg, Germany
Research Site
Kita-ku, Japan
Research Site
Osaka, Japan
...and 35 more locations
Time from randomization to death from any cause.
Time frame: Up to 46 months.