A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants with Chronic Kidney Disease and High Blood Pressure (NMRR ID: 24-03646-G5X)
Abbreviated Title: BaxDuo-PacificStudy Phase: III
Patients (Population): CKD
Intervention / Treatment: Baxdrostat in combination with Dapagliflozin This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
Comparator: Baxdrostat in combination with Dapagliflozin
Primary Outcome: The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of >= 50% sustained decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN.
Clinicaltrials.gov hyperlink: https://clinicaltrials.gov/study/NCT06742723?locStr=Malaysia&country=MY&cond=CKD&aggFilters=status:rec&rank=8
Status:
Recruiting
Sites: [Click on map to show site list]
Last updated: 27/10/2025 15:22:22
Note: States highlighted in colour other than grey indicate the state of the participating site(s) in Malaysia. Please click on the state to view the list of participating sites / hospitals in the state that are involved in the research.