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Baxdrostat with or without dapagliflozin for chronic kidney disease and high blood pressure

Tests baxdrostat plus dapagliflozin versus baxdrostat alone in adults with kidney disease.

Key facts

Who runs it
AstraZeneca AB
Where
Sofia and Yambol, BulgariaSee the 2 sitesAlso in 1 other country, 4 sites
Registry title
A Phase IIb study to evaluate the effect of combination of dapagliflozin and baxdrostat compared with baxdrostat alone in participants with chronic kidney disease and high blood pressure
Status
Recruiting
Phase
Phase 2
People taking part
18 people, planned
Started
16 Apr 2026
Expected to end
19 Feb 2027
Type of study
Interventional
Record updated
17 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic kidney disease and high blood pressure. It tests baxdrostat with dapagliflozin against baxdrostat alone on protein in the urine.

Age
18 years or older
Sex
All sexes can join
Disease stage
Chronic kidney disease with eGFR ≥ 30 and < 90 mL/min/1.73 m2 and UACR > 200 mg/g and < 5000 mg/g. History of high blood pressure with SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at randomisation.
Earlier treatment
Stable and maximum tolerated daily dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks before screening, if not medically contraindicated. No mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics or potassium binders within 4 weeks before screening.
Biomarker or test result
Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45, or ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45.

Main reasons for not taking part

  • Any dialysis or acute kidney injury within 3 months before screening
  • Blood pressure above 180 mmHg systolic or 110 mmHg diastolic at screening
  • Known high potassium (≥ 5.5 mmol/L within 3 months) or sodium < 135 mmol/L
  • Type 1 diabetes, or uncontrolled type 2 diabetes (HbA1C > 10.5% (91 mmol/mol))
  • Heart failure class IV, severe liver impairment (Child-Pugh C) or history of adrenal insufficiency

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent
  • Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
  • Participants with UACR > 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 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
  • Participants with: (a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2. (b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants

Who cannot take part

  • Any dialysis (including for acute kidney injury) within 3 months prior to the screening
  • Any acute kidney injury within 3 months prior to the screening visit
  • Prohibited concomitant medications
  • 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
  • New York Heart Association functional HF class IV at screening
  • Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
  • Documented history of adrenal insufficiency
  • Known hyperkalaemia, defined as potassium of ≥ 5.5mmol/L within 3 months before screening
  • Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit)
  • Diabetes mellitus: (a) T1DM at the screening visit (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91mmol/mol)
  • Any use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders within 4 weeks prior to screening
  • Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening

Where in Bulgaria

Also in 1 other country, 4 sites

  • Medical Center Medicabilis Ltd.Sofia, BulgariaNo longer taking part
  • Medical Center Berbatov Ltd.Yambol, BulgariaNo longer taking part

About the trial

What the trial wants to find out

To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/placebo at reducing albuminuria

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Baxdrostat with or without dapagliflozin for chronic kidney disease and high blood pressureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
17 September 2026