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Investigating Baxdrostat and Dapagliflozin for Chronic Kidney Disease and High Blood Pressure

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

Phase 3 Interventional AstraZeneca · NCT06742723

This study is testing if a new combination of baxdrostat and dapagliflozin can help people with chronic kidney disease and high blood pressure avoid serious kidney problems and heart issues.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations759 sites (Fairhope, Alabama and 758 other locations)
Trial IDNCT06742723 on ClinicalTrials.gov

What this trial studies

This international, multicenter, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin in participants suffering from chronic kidney disease (CKD) and hypertension (HTN). The study will compare the effects of the drug combination against a placebo and dapagliflozin alone, focusing on reducing the risk of significant kidney decline, kidney failure, or cardiovascular death. Participants will undergo a 4-week run-in period followed by regular site visits for monitoring throughout the study duration. The study will conclude once a predetermined number of primary endpoint events have occurred.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease and hypertension, specifically those with certain levels of eGFR and UACR.

Not a fit: Patients with eGFR below 30 mL/min/1.73 m2 or those not meeting the specific hypertension criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that significantly reduces the risk of kidney failure and cardiovascular mortality in patients with chronic kidney disease and high blood pressure.

How similar studies have performed: Other studies have shown promising results with similar drug combinations in managing chronic kidney disease and hypertension, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Fairhope, Alabama and 758 other locations

+709 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 pressureBaxdrostatDapagliflozinEvent-DrivenOutcome
Last reviewed 2026-06-13 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.