A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
NCT06742723 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5000
Last updated 2026-04-30
Summary
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
Conditions
- Chronic Kidney Disease and Hypertension
Interventions
- DRUG
-
Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
- DRUG
-
Placebo/dapagliflozin
dapagliflozin tablet placebo tablet
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-03
- Primary Completion
- 2029-12-18
- Completion
- 2029-12-18
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Czechia
- Denmark
- Egypt
- France
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- Peru
- Philippines
- Poland
- Romania
- Saudi Arabia
- Serbia
- Singapore
- Slovakia
- South Africa
- South Korea
- Spain
- Sweden
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
- Vietnam
Study Locations
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