Who is eligible for clinical trial NCT06268873?

Participants must meet the protocol's inclusion criteria for Chronic Kidney Disease and Hypertension. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06268873 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-06-25

A 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. (NCT06268873)

A Phase III, Randomised, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants With CKD and High Blood Pressure

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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 untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-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 12-weeks (approximately), where reassessment of eGFR 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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (13 items).

Location: Research Site — Fairhope, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Systolic blood pressure \> 180 mmHg, or DBP \> 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
Serum sodium \< 135 mmol/L at the Screening Visit, determined as per central laboratory.
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).
New York Heart Association functional HF class IV at screening.
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.
Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
Any acute kidney injury within 3 months prior to the Screening Visit
History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (565 Sites)

Showing the first 25 of 565 sites.

Research Site — Fairhope, Alabama
Research Site — Phoenix, Arizona
Research Site — Surprise, Arizona
Research Site — Tucson, Arizona
Research Site — Searcy, Arkansas
Research Site — Beverly Hills, California
Research Site — Canyon Country, California
Research Site — Fremont, California
Research Site — Fullerton, California
Research Site — Lincoln, California
Research Site — Los Alamitos, California
Research Site — San Francisco, California
Research Site — Stanford, California
Research Site — Tarzana, California
Research Site — Arvada, Colorado
Research Site — Denver, Colorado
Research Site — New Britain, Connecticut
Research Site — Boca Raton, Florida
Research Site — Boynton Beach, Florida
Research Site — Edgewater, Florida
Research Site — Fort Lauderdale, Florida
Research Site — Hialeah, Florida
Research Site — Hollywood, Florida
Research Site — Jacksonville, Florida
Research Site — Jacksonville Beach, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: This study consists of a screening, a 4-week dapagliflozin run-in period for participants untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either...

More studies in Chronic Kidney Disease and Hypertension

Explore by condition: All Chronic Kidney Disease and Hypertension clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗