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Phase 3

Baxdrostat & DapagliflozinA Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Sponsor:

AstraZeneca

Code:

NCT06268873

Conditions

Chronic Kidney Disease and Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Baxdrostat/dapagliflozin

Dapagliflozin in combination with placebo

Study Details

Brief summary:

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.

This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.

Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint.

In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

Conditions

Chronic Kidney Disease and Hypertension

Study ID

NCT06268873

Start date

Mar 29, 2024

Status verified date

Sep, 2025

Completion date

Feb 11, 2028

Anticipated

Primary completion date

Feb 11, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
2. Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
6. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:

for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit

Exclusion Criteria:

1. Systolic blood pressure > 180 mmHg, or DBP > 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 at the Screening Visit, determined as per central laboratory.
4. Diabetes mellitus:

(a) T1DM at Screening Visit: (i) 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.

(ii) 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.

(b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).
5. New York Heart Association functional HF class IV at screening.
6. 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.
7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
8. Any acute kidney injury within 3 months prior to the Screening Visit
9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.

Study Design

Enrollment

2500 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 dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

active comparator: Dapagliflozin

Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily

Interventions

Baxdrostat/dapagliflozin

baxdrostat tablet

dapagliflozin tablet

Dapagliflozin in combination with placebo

dapagliflozin tablet

placebo tablet

Primary outcome measure

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. [ Time Frame: Baseline - 2 years + 6 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

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Fairhope, Alabama, United States, 36532

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Phoenix, Arizona, United States, 85016

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Surprise, Arizona, United States, 85374

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Tucson, Arizona, United States, 85710

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Searcy, Arkansas, United States, 72143

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Beverly Hills, California, United States, 90211

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Canyon Country, California, United States, 91351

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Fremont, California, United States, 94538

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Fullerton, California, United States, 92835

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Lincoln, California, United States, 95648

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Los Alamitos, California, United States, 90720

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San Francisco, California, United States, 94110

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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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Denver, Colorado, United States, 80220

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New Britain, Connecticut, United States, 06051

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Boca Raton, Florida, United States, 33487

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Boynton Beach, Florida, United States, 33435

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Coral Gables, Florida, United States, 33134

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Edgewater, Florida, United States, 32132

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Fort Lauderdale, Florida, United States, 33316

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Hialeah, Florida, United States, 33012

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Hollywood, Florida, United States, 33021

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Jacksonville, Florida, United States, 32204

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Lake City, Florida, United States, 32055

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Lake Worth, Florida, United States, 33467

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Melbourne, Florida, United States, 32901

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Miami, Florida, United States, 33165

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Miami Lakes, Florida, United States, 33014

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New Port Richey, Florida, United States, 34652

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Ocoee, Florida, United States, 34761

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Orlando, Florida, United States, 32806

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Orlando, Florida, United States, 32808

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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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Winter Haven, Florida, United States, 33880

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Atlanta, Georgia, United States, 30344

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Conyers, Georgia, United States, 30094

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Macon, Georgia, United States, 31210

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Champaign, Illinois, United States, 61822

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Hazel Crest, Illinois, United States, 60429

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Huntley, Illinois, United States, 60142

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Rockford, Illinois, United States, 61107

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Evansville, Indiana, United States, 47714

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Fort Wayne, Indiana, United States, 46804

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Hutchinson, Kansas, United States, 67502

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Wichita, Kansas, United States, 67214

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Bethesda, Maryland, United States, 20889

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Lanham, Maryland, United States, 20706

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Boston, Massachusetts, United States, 02114

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Boston, Massachusetts, United States, 02115

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New Bedford, Massachusetts, United States, 02740

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Detroit, Michigan, United States, 48202

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Pontiac, Michigan, United States, 48341

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Saint Joseph, Michigan, United States, 49085

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City of Saint Peters, Missouri, United States, 63376

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Columbia, Missouri, United States, 65201

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Kansas City, Missouri, United States, 64111

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Kansas City, Missouri, United States, 64128

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Kansas City, Missouri, United States, 64151

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St Louis, Missouri, United States, 63136

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Eatontown, New Jersey, United States, 07724

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Binghamton, New York, United States, 13905

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Buffalo, New York, United States, 14203

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Manhasset, New York, United States, 11030

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Middletown, New York, United States, 10940

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New York, New York, United States, 10016

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Niagara Falls, New York, United States, 14304

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Orchard Park, New York, United States, 14127

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Rockville Centre, New York, United States, 11570

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Greenville, North Carolina, United States, 27834

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Jacksonville, North Carolina, United States, 28546

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New Bern, North Carolina, United States, 28562

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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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Columbus, Ohio, United States, 43213

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Columbus, Ohio, United States, 43215

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Maumee, Ohio, United States, 43537

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Chester, Pennsylvania, United States, 19013

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Uniontown, Pennsylvania, United States, 15401

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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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Providence, Rhode Island, United States, 02904

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Charleston, South Carolina, United States, 29414

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Columbia, South Carolina, United States, 29203

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Sioux Falls, South Dakota, United States, 57104

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Chattanooga, Tennessee, United States, 37421

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Kingsport, Tennessee, United States, 37660

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Memphis, Tennessee, United States, 38105

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Memphis, Tennessee, United States, 38115

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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, 78751

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Dallas, Texas, United States, 75230

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Dallas, Texas, United States, 75231

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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, 77040

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Houston, Texas, United States, 77084

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Houston, Texas, United States, 77099

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Humble, Texas, United States, 77338

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Lewisville, Texas, United States, 75057

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Odessa, Texas, United States, 79761

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Pasadena, Texas, United States, 77504

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San Antonio, Texas, United States, 78212

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San Antonio, Texas, United States, 78231

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Salt Lake City, Utah, United States, 84115

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Salt Lake City, Utah, United States, 84132

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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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Richmond, Virginia, United States, 23249

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Salem, Virginia, United States, 24153

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Woodbridge, Virginia, United States, 22192

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Edmonton, Alberta, Canada, T6G 2G3

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Vancouver, British Columbia, Canada, V5Y 3W2

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Vancouver, British Columbia, Canada, V6Z 1Y6

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Winnipeg, Manitoba, Canada, R2V 3M3

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Halifax, Nova Scotia, Canada, B3H 1V7

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Sydney, Nova Scotia, Canada, B1P 1P3

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Brampton, Ontario, Canada, L6S 0C6

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Concord, Ontario, Canada, L4K 4M2

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London, Ontario, Canada, N6A 5A5

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Oshawa, Ontario, Canada, L1G 2B9

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Stoney Creek, Ontario, Canada, L8J 3W2

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Toronto, Ontario, Canada, M4G 3E8

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Toronto, Ontario, Canada, M5C 2T2

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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, H2X 0A9

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Montreal, Quebec, Canada, H4J 1C5

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Québec, Quebec, Canada, G1R 2J6

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Sherbrooke, Quebec, Canada, J1H 5N4

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Saint John, Canada, E2L 4L2

More Information

Sponsor

AstraZeneca

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by AstraZeneca on 2025-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.