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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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506460-14-00
Acronym
D6972C00002
Enrollment
1134
Registered
2025-04-14
Start date
2025-05-07
Completion date
Unknown
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD) and hypertension.

Brief summary

Time to the first occurrence of any of the components of the composite of: 1. ≥ 50% sustained decline in eGFR 2. Onset of kidney failure: • Sustained eGFR < 15 mL/min/1.73 m2 or • Chronic dialysis treatment or • Receiving a kidney transplant or • Death with a renal primary cause (death due to kidney failure when dialysis is not given) 3. CV death

Detailed description

Change from baseline in UACR., Change from baseline in mean SBP., Time to the first occurrence of any of the components of the composite of: • CV death • HF with and without hospitalisation • MI • Stroke, CV death., Death.

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to the first occurrence of any of the components of the composite of: 1. ≥ 50% sustained decline in eGFR 2. Onset of kidney failure: • Sustained eGFR < 15 mL/min/1.73 m2 or • Chronic dialysis treatment or • Receiving a kidney transplant or • Death with a renal primary cause (death due to kidney failure when dialysis is not given) 3. CV death

Secondary

MeasureTime frame
Change from baseline in UACR., Change from baseline in mean SBP., Time to the first occurrence of any of the components of the composite of: • CV death • HF with and without hospitalisation • MI • Stroke, CV death., Death.

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026