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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 130 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Placebo controlled

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Baxdrostat/dapagliflozin
    baxdrostat tablet dapagliflozin tablet
    Other names:
    • Baxdrostat CIN-107
Active Comparator
Dapagliflozin 		Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily
  • Drug: Dapagliflozin in combination with placebo
    dapagliflozin tablet placebo tablet

Recruiting Locations

Research Site
Fairhope, Alabama 36532

Research Site
Phoenix, Arizona 85016

Research Site
Surprise, Arizona 85374

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Tucson, Arizona 85710

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Searcy, Arkansas 72143

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Beverly Hills, California 90211

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Canyon Country, California 91351

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Fremont, California 94538

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Fullerton, California 92835

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Lincoln, California 95648

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Los Alamitos, California 90720

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San Francisco, California 94110

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Stanford, California 94305

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Tarzana, California 91356

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Arvada, Colorado 80002

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Denver, Colorado 80220

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New Britain, Connecticut 06051

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Boca Raton, Florida 33431

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Boynton Beach, Florida 33435

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Coral Gables, Florida 33134

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Edgewater, Florida 32132

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Fort Lauderdale, Florida 33316

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Hialeah, Florida 33012

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Hollywood, Florida 33021

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Jacksonville, Florida 32204

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Lake City, Florida 32055

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Lake Worth, Florida 33467

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Melbourne, Florida 32901

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Miami Lakes, Florida 33014

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Miami, Florida 33165

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New Port Richey, Florida 34652

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Ocoee, Florida 34761

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Orlando, Florida 32806

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Orlando, Florida 32808

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Port Charlotte, Florida 33952

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Port Orange, Florida 32127

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Riverview, Florida 33578

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Winter Haven, Florida 33880

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Atlanta, Georgia 30344

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Conyers, Georgia 30094

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Macon, Georgia 31210

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Champaign, Illinois 61822

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Hazel Crest, Illinois 60429

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Huntley, Illinois 60142

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Rockford, Illinois 61107

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Evansville, Indiana 47714

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Fort Wayne, Indiana 46804

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Hutchinson, Kansas 67502

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Wichita, Kansas 67214

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Bethesda, Maryland 20889

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Lanham, Maryland 20706

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Boston, Massachusetts 02114

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Boston, Massachusetts 02115

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New Bedford, Massachusetts 02740

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Detroit, Michigan 48202

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Pontiac, Michigan 48341

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Saint Joseph, Michigan 49085

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Columbia, Missouri 65201

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Kansas City, Missouri 64111

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Kansas City, Missouri 64128

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Kansas City, Missouri 64151

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Saint Louis, Missouri 63136

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Saint Peters, Missouri 63376

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Eatontown, New Jersey 07724

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Binghamton, New York 13905

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Buffalo, New York 14203

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Manhasset, New York 11030

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Middletown, New York 10940

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New York, New York 10016

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Niagara Falls, New York 14304

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Orchard Park, New York 14127

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Rockville Centre, New York 11570

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Greenville, North Carolina 27834

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Jacksonville, North Carolina 28546

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New Bern, North Carolina 28562

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Statesville, North Carolina 28625

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Wilmington, North Carolina 28401

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Wilmington, North Carolina 28412

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Columbus, Ohio 43213

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Columbus, Ohio 43215

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Maumee, Ohio 43537

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Chester, Pennsylvania 19013

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Langhorne, Pennsylvania 19047

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Uniontown, Pennsylvania 15401

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East Providence, Rhode Island 02914

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East Providence, Rhode Island 02915

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Providence, Rhode Island 02904

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Charleston, South Carolina 29414

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Columbia, South Carolina 29203

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Sioux Falls, South Dakota 57104

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Chattanooga, Tennessee 37421

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Kingsport, Tennessee 37660

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Memphis, Tennessee 38105

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Memphis, Tennessee 38115

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Arlington, Texas 76015

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Austin, Texas 78726

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Austin, Texas 78751

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Dallas, Texas 75230

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Dallas, Texas 75231

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Dallas, Texas 75246

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Houston, Texas 77004

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Houston, Texas 77040

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Houston, Texas 77084

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Houston, Texas 77099

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Humble, Texas 77338

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Lewisville, Texas 75057

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Odessa, Texas 79761

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Pasadena, Texas 77504

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San Antonio, Texas 78212

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San Antonio, Texas 78231

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Salt Lake City, Utah 84115

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Salt Lake City, Utah 84132

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Burlington, Vermont 05401

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Arlington, Virginia 22205

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Manassas, Virginia 20110

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Newport News, Virginia 23606

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Richmond, Virginia 23249

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Salem, Virginia 24153

Research Site
Woodbridge, Virginia 22192

More Details

NCT ID
NCT06268873
Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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