Recruiting
Phase 3

Baxdrostat & Dapagliflozin

Sponsor:

AstraZeneca

Code:

NCT06742723

Conditions

Chronic Kidney Disease and Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baxdrostat/dapagliflozin

Placebo/dapagliflozin

Study Details

Brief 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

Study ID

NCT06742723

Start date

Mar 3, 2025

Status verified date

Aug, 2026

Completion date

Dec 18, 2029

Anticipated

Primary completion date

Dec 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baxdrostat/dapagliflozin

Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

placebo comparator: Placebo/dapagliflozin

Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.

Interventions

Baxdrostat/dapagliflozin

baxdrostat tablet

dapagliflozin tablet

Placebo/dapagliflozin

dapagliflozin tablet

placebo tablet

Primary outcome measure

  • To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. [ Time Frame: Up to 37 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

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Fairhope, Alabama, United States, 36532

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Surprise, Arizona, United States, 85374

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Tucson, Arizona, United States, 85710

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Beverly Hills, California, United States, 90211

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Concord, California, United States, 94520

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Fremont, California, United States, 94538

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Fullerton, California, United States, 92835

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Los Alamitos, California, United States, 90720

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Los Angeles, California, United States, 90073

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Stanford, California, United States, 94305

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Tarzana, California, United States, 91356

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Arvada, Colorado, United States, 80002

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New Britain, Connecticut, United States, 06051

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Washington D.C., District of Columbia, United States, 20037

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Boca Raton, Florida, United States, 33487

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Boynton Beach, Florida, United States, 33435

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Edgewater, Florida, United States, 32132

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Fort Lauderdale, Florida, United States, 33316

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Hollywood, Florida, United States, 33021

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Jacksonville Beach, Florida, United States, 32250

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Lake City, Florida, United States, 32055

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Lakeland, Florida, United States, 33805

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Melbourne, Florida, United States, 32901

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Ocoee, Florida, United States, 34761

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Port Charlotte, Florida, United States, 33952

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Port Orange, Florida, United States, 32127

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Riverview, Florida, United States, 33578

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Atlanta, Georgia, United States, 30328

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Austell, Georgia, United States, 30106

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Brunswick, Georgia, United States, 31520

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Conyers, Georgia, United States, 30094

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Decatur, Georgia, United States, 30030

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East Point, Georgia, United States, 30344

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Lawrenceville, Georgia, United States, 30046

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Riverdale, Georgia, United States, 30274

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Champaign, Illinois, United States, 61822

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Maywood, Illinois, United States, 60153

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Rockford, Illinois, United States, 61107

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Indianapolis, Indiana, United States, 46202

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Iowa City, Iowa, United States, 52242

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West Des Moines, Iowa, United States, 50266

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Hutchinson, Kansas, United States, 67502

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Kansas City, Kansas, United States, 66112

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Wichita, Kansas, United States, 67214

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Metairie, Louisiana, United States, 70006

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West Monroe, Louisiana, United States, 71291

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Bethesda, Maryland, United States, 20889

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Boston, Massachusetts, United States, 02115

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Braintree, Massachusetts, United States, 02184

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New Bedford, Massachusetts, United States, 02740

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Worcester, Massachusetts, United States, 01608

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Ann Arbor, Michigan, United States, 48109

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Detroit, Michigan, United States, 48202

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Garden City, Michigan, United States, 48135

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Saint Joseph, Michigan, United States, 49085

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Kansas City, Missouri, United States, 64112

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Kansas City, Missouri, United States, 64151

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St Louis, Missouri, United States, 63136

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Norfolk, Nebraska, United States, 68701

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Eatontown, New Jersey, United States, 07724

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Albany, New York, United States, 12205

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Buffalo, New York, United States, 14203

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New York, New York, United States, 10016

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Greenville, North Carolina, United States, 27834

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Hickory, North Carolina, United States, 28601

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Jacksonville, North Carolina, United States, 28546

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Kinston, North Carolina, United States, 28504

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Morehead City, North Carolina, United States, 28557

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New Bern, North Carolina, United States, 28562

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Raleigh, North Carolina, United States, 27609

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Rocky Mount, North Carolina, United States, 27804

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Sanford, North Carolina, United States, 27330

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Statesville, North Carolina, United States, 28625

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Wilmington, North Carolina, United States, 28401

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Wilmington, North Carolina, United States, 28412

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Winston-Salem, North Carolina, United States, 27103

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Canton, Ohio, United States, 44718

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Cincinnati, Ohio, United States, 45212

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Cincinnati, Ohio, United States, 45219

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Columbus, Ohio, United States, 43210

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Columbus, Ohio, United States, 43213

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Columbus, Ohio, United States, 43215

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Bridgeville, Pennsylvania, United States, 15017

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Butler, Pennsylvania, United States, 16001

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Exton, Pennsylvania, United States, 19341

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Media, Pennsylvania, United States, 19063

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East Providence, Rhode Island, United States, 02914

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East Providence, Rhode Island, United States, 02915

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Charleston, South Carolina, United States, 29414

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Columbia, South Carolina, United States, 29203

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Chattanooga, Tennessee, United States, 37421

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Knoxville, Tennessee, United States, 37912

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Knoxville, Tennessee, United States, 37938

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Nashville, Tennessee, United States, 37232

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Arlington, Texas, United States, 76015

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Austin, Texas, United States, 78726

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Austin, Texas, United States, 78735

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Austin, Texas, United States, 78751

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Dallas, Texas, United States, 75234

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Dallas, Texas, United States, 75246

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Houston, Texas, United States, 77004

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Houston, Texas, United States, 77099

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Humble, Texas, United States, 77346

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Pasadena, Texas, United States, 77504

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San Antonio, Texas, United States, 78212

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South Salt Lake, Utah, United States, 84115

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Burlington, Vermont, United States, 05401

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Arlington, Virginia, United States, 22205

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Manassas, Virginia, United States, 20110

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Newport News, Virginia, United States, 23606

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Woodbridge, Virginia, United States, 22192

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Seattle, Washington, United States, 98195

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Edmonton, Alberta, Canada, T6G 2P4

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Surrey, British Columbia, Canada, V3T 0H1

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Winnipeg, Manitoba, Canada, R2V 3M3

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Saint John, New Brunswick, Canada, E2L 4L2

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Halifax, Nova Scotia, Canada, B3H 1V7

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Etobicoke, Ontario, Canada, M9W 6V1

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London, Ontario, Canada, N6A 5A5

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Oshawa, Ontario, Canada, L1G 2B9

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Sarnia, Ontario, Canada, N7T 4X3

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Toronto, Ontario, Canada, M3M 0B2

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Toronto, Ontario, Canada, M4G 3E8

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Toronto, Ontario, Canada, M5G 2N2

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Toronto, Ontario, Canada, M9V 4B4

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Waterloo, Ontario, Canada, N2T 0C1

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Laval, Quebec, Canada, H7T 2P5

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Montreal, Quebec, Canada, H1T 2M4

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Montreal, Quebec, Canada, H2X 0A9

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Montreal, Quebec, Canada, H4J 1C5

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Montreal, Quebec, Canada, H4J 1E3

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Québec, Quebec, Canada, G1R 2J6

More Information

Sponsor

AstraZeneca

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Chronic kidney disease
  • Hypertension
  • Blood pressure
  • Baxdrostat
  • Dapagliflozin
  • Event-Driven
  • Outcome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-26.