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Dapagliflozin added to baxdrostat to lower urine albumin in people with chronic kidney disease and high blood pressure

A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

Phase 2 Interventional AstraZeneca · NCT07222917

This study will test whether adding dapagliflozin to baxdrostat lowers urine albumin more than baxdrostat with placebo in adults with chronic kidney disease and high blood pressure.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment218 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations71 sites (Surprise, Arizona and 70 other locations)
Trial IDNCT07222917 on ClinicalTrials.gov

What this trial studies

This Phase IIb, randomized, double-blind, parallel-group multicenter trial enrolls adults with chronic kidney disease and hypertension to receive either baxdrostat plus dapagliflozin or baxdrostat plus matching placebo. Participants may have type 2 diabetes or not, and those on SGLT2 inhibitors at screening may undergo a washout before randomization with stratification by diabetes status. The primary outcome is change from baseline in urinary albumin-to-creatinine ratio (UACR), with safety and tolerability monitored throughout. The study uses standard inclusion criteria for eGFR, UACR, blood pressure, and background ACE inhibitor or ARB therapy.

Who should consider this trial

Good fit: Adults aged 18 or older with chronic kidney disease, eGFR between 30 and 90 mL/min/1.73 m2, UACR between >200 and <5000 mg/g, a history of hypertension with specified systolic blood pressure thresholds, and on a stable ACE inhibitor or ARB dose are the intended participants.

Not a fit: People with eGFR below 30 mL/min/1.73 m2, UACR outside the specified range, uncontrolled blood pressure, or contraindications to study drugs (including certain electrolyte abnormalities or pregnancy) are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, the combination could further reduce albuminuria and potentially slow kidney disease progression beyond baxdrostat alone.

How similar studies have performed: SGLT2 inhibitors such as dapagliflozin have previously reduced albuminuria and slowed CKD progression in large trials, but combining dapagliflozin with baxdrostat is a novel approach with limited prior data.

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 eGFR ≥ 30 and \< 90 mL/min/1.73 m2 at screening
3. Participants with UACR \> 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 daily tolerated dose of either an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to the screening visit, if not medically contraindicated.
6. Participants with:

   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2.
7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.

Exclusion Criteria:

1. Systolic blood pressure \> 180 mmHg, or diastolic blood pressure \> 110 mmHg at screening.
2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening
3. Serum sodium \< 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
4. Diabetes mellitus:

   1. T1DM at the screening visit
   2. Uncontrolled T2DM at screening: HbA1C \> 10.5% (\> 91 mmol/mol)
5. New York Heart Association functional HF class IV at screening
6. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), aldosterone synthase inhibitors, 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
7. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening HF within previous 3 months prior to randomisation.
8. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
9. Documented history of adrenal insufficiency.
10. Any dialysis (including for acute kidney injury) within 3 months prior to the screening
11. Any acute kidney injury within 3 months prior to the screening visit.
12. Prohibited concomitant medications

Where this trial is running

Surprise, Arizona and 70 other locations

+21 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.