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Investigating the effects of baxdrostat and dapagliflozin on kidney disease and high blood pressure

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

Phase 3 Interventional AstraZeneca · NCT06268873

This study is testing if a new combination of two medications can help adults with kidney disease and high blood pressure feel better and improve their health over two years.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2500 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations624 sites (Fairhope, Alabama and 623 other locations)
Trial IDNCT06268873 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of a combination treatment of baxdrostat and dapagliflozin in adults with chronic kidney disease (CKD) and hypertension. Participants will undergo a screening phase followed by a 4-week run-in period with dapagliflozin, then a 24-month double-blind phase where they will receive either the combination treatment or dapagliflozin alone. After this, there will be a 6-week open-label period where all participants will receive dapagliflozin. The study will assess changes in kidney function and blood pressure throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease and hypertension.

Not a fit: Patients with severely elevated blood pressure or those not meeting the specific kidney function criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of chronic kidney disease in patients with high blood pressure.

How similar studies have performed: Other studies have shown promise in using SGLT2 inhibitors for CKD management, making this approach a potentially valuable addition to existing treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fairhope, Alabama and 623 other locations

+574 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney Disease and HypertensionChronic kidney diseaseHypertensionBlood pressureBaxdrostatDapagliflozin
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.