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
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
- Chronic Kidney Disease and Hypertension
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 5,000
- Started
- 3 March 2025
- Main results due
- 18 December 2029
- Study sites
- 771
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria:
1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
2. Participants with (a) or (b):
a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
* UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
* UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
* UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
(b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
* UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
* UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
3. \[obsolete\]
4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
6. Participants with:
1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values)
Exclusion Criteria:
1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
4\. Participants with T1DM will be excluded, except:
1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
5 Uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
6 New York Heart Association functional HF class IV at screening.
7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
8 Documented history of adrenal insufficiency.
9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
10 Any acute kidney injury within 3 months prior to the Screening Visit.
11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(771)
Research Site
Fairhope, Alabama, United States
Recruiting
Research Site
Surprise, Arizona, United States
Recruiting
Research Site
Tucson, Arizona, United States
Recruiting
Research Site
Beverly Hills, California, United States
Recruiting
Research Site
Canoga Park, California, United States
Withdrawn
Research Site
Concord, California, United States
Recruiting
Research Site
Fremont, California, United States
Recruiting
Research Site
Fullerton, California, United States
Recruiting
Research Site
Inglewood, California, United States
Withdrawn
Research Site
Los Alamitos, California, United States
Recruiting
Research Site
Los Angeles, California, United States
Recruiting
Research Site
San Diego, California, United States
Withdrawn
Research Site
San Francisco, California, United States
Withdrawn
Research Site
Stanford, California, United States
Recruiting
Research Site
Tarzana, California, United States
Recruiting
Research Site
Arvada, Colorado, United States
Recruiting
Research Site
Denver, Colorado, United States
Withdrawn
Research Site
New Britain, Connecticut, United States
Recruiting
Research Site
Washington D.C., District of Columbia, United States
Recruiting
Research Site
Boca Raton, Florida, United States
Recruiting
Research Site
Boynton Beach, Florida, United States
Recruiting
Research Site
Edgewater, Florida, United States
Recruiting
Research Site
Fort Lauderdale, Florida, United States
Recruiting
Research Site
Hollywood, Florida, United States
Recruiting
Research Site
Jacksonville Beach, Florida, United States
Recruiting
Research Site
Lake City, Florida, United States
Recruiting
Research Site
Lakeland, Florida, United States
Recruiting
Research Site
Melbourne, Florida, United States
Recruiting
Research Site
Miami Lakes, Florida, United States
Suspended
Research Site
Ocoee, Florida, United States
Recruiting
Research Site
Port Charlotte, Florida, United States
Recruiting
Research Site
Port Orange, Florida, United States
Recruiting
Research Site
Riverview, Florida, United States
Recruiting
Research Site
Atlanta, Georgia, United States
Recruiting
Research Site
Augusta, Georgia, United States
Withdrawn
Research Site
Austell, Georgia, United States
Recruiting
Research Site
Brunswick, Georgia, United States
Recruiting
Research Site
Conyers, Georgia, United States
Recruiting
Research Site
Decatur, Georgia, United States
Recruiting
Research Site
East Point, Georgia, United States
Recruiting
Research Site
Lawrenceville, Georgia, United States
Recruiting
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Riverdale, Georgia, United States
Recruiting
Research Site
Honolulu, Hawaii, United States
Suspended
Research Site
Idaho Falls, Idaho, United States
Not yet recruiting
Research Site
Champaign, Illinois, United States
Recruiting
Research Site
Maywood, Illinois, United States
Recruiting
Research Site
Rockford, Illinois, United States
Recruiting
Research Site
Evansville, Indiana, United States
Withdrawn
Research Site
Indianapolis, Indiana, United States
Recruiting
Research Site
Iowa City, Iowa, United States
Recruiting
Research Site
West Des Moines, Iowa, United States
Recruiting
Research Site
Hutchinson, Kansas, United States
Recruiting
Research Site
Kansas City, Kansas, United States
Recruiting
Research Site
Wichita, Kansas, United States
Recruiting
Research Site
Kenner, Louisiana, United States
Withdrawn
Research Site
Metairie, Louisiana, United States
Recruiting
Research Site
West Monroe, Louisiana, United States
Recruiting
Research Site
Bethesda, Maryland, United States
Recruiting
Research Site
Boston, Massachusetts, United States
Withdrawn
Research Site
Boston, Massachusetts, United States
Recruiting
Showing 60 of 771 sites — filter to narrow it down. 671 of the 771 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06742723. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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