At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Baxdrostat/dapagliflozin (drug), Baxdrostat/Placebo (drug)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- Baxdrostat/dapagliflozin — drug: baxdrostat tablet dapagliflozin tablet · Baxdrostat/Placebo — drug: baxdrostat tablet placebo tablet
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether taking a medicine called dapagliflozin together with another medicine called baxdrostat works better than baxdrostat alone to reduce protein in the urine (albuminuria) in people with long-term kidney disease and high blood pressure. Too much protein in the urine is a sign of kidney damage. The study is run by AstraZeneca.
Who can take part
- Adults aged 18 or over, of any sex or gender.
- Kidney function (called eGFR) between 30 and below 90 mL/min/1.73 m2 at screening.
- Protein in the urine (called UACR) above 200 mg/g but below 5000 mg/g at screening.
- A history of high blood pressure, with the top blood pressure number (systolic) of 130 mmHg or more at screening and 120 mmHg or more at the randomisation visit.
- Already taking a stable, highest tolerated daily dose of either an ACE inhibitor or an ARB blood pressure medicine (but not both) for at least 4 weeks before screening, unless there is a medical reason not to.
- Blood potassium within a set safe range: between 3.0 and 4.8 mmol/L if eGFR is 45 or above, or between 3.0 and 4.5 mmol/L if eGFR is below 45.
- Women who can become pregnant must use contraception in line with local rules for clinical studies.
Who may not be able to
- Blood pressure above 180 mmHg (top number) or 110 mmHg (bottom number) at screening.
- Known high potassium in the blood (5.5 mmol/L or more) within 3 months before screening.
- Low blood sodium (below 135 mmol/L) at the screening visit or within 4 weeks before it.
- Type 1 diabetes, or uncontrolled type 2 diabetes with HbA1c above 10.5% (above 91 mmol/mol).
- Severe heart failure (New York Heart Association class IV) at screening.
- Use of certain medicines within 4 weeks before screening, including spironolactone, eplerenone, finerenone, similar potassium-sparing water tablets (such as triamterene or amiloride), or potassium-lowering medicines (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate).
- Stroke, mini-stroke (transient ischaemic attack), heart valve implant or replacement, carotid surgery or angioplasty, a heart attack or acute coronary syndrome, or a hospital stay for worsening heart failure within 3 months before joining.
- Severe liver problems (Child-Pugh Class C).
- A history of adrenal insufficiency (the adrenal glands not making enough hormones).
- Any dialysis, including for sudden kidney injury, within 3 months before screening.
- Sudden kidney injury within 3 months before screening.
- Taking medicines that are not allowed in this study — Not stated — ask the trial team.
What taking part involves
- • Taking dapagliflozin plus baxdrostat, or baxdrostat on its own, to compare the effects on protein in the urine.
- • Details of how the medicines are taken — Not stated — ask the trial team.
Time commitment: How long the study lasts, how many visits there are, and what tests are involved — Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 222
- Started
- 2025-12-05
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for chronic kidney disease and hypertension
- • Phase2 - 222 participants
- • International, Multicenter and Double-Blind study
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic kidney disease and hypertension
Where?
- • Dundee - Research Site
- • Liverpool - Research Site
- • London - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.
More detail
This is a Phase IIb, randomised, multicentre, double-blind, parallel-group study aiming to determine the effect on albuminuria, as well as safety, of baxdrostat/dapagliflozin compared with baxdrostat/placebo, when given to participants with CKD and high blood pressure. Study population will include participants ≥ 18 years old with CKD. Participants with or without a diagnosis of T2DM and with or without an SGLT2i treatment at screening are eligible for the study. The study will include an optional pre-screening period, where participants will be assessed for at least one of the following parameters: eGFR, UACR, potassium, sodium, and BP. Participants who are being treated with SGLT2i at the time of the screening visit will complete a washout period After screening and initial confirmation of eligibility, participants will be randomised to receive either baxdrostat/dapagliflozin or baxdrostat/placebo. For randomisation there will be stratification and capping linked to T2DM status. The primary objective is to assess the effect of baxdrostat/dapagliflozin compared with baxdrostat/matching placebo on albuminuria, which will be evaluated by change from baseline in UACR. The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally, whichever occurs last. A participant is considered to have completed the study if they have completed all periods of the study including the last scheduled procedure shown in the SoA.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participants of any sex and gender must be ≥ 18 years of age at the time of signing the agreement to take part.
- ✓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...
Who cannot take part
- ✗Systolic blood pressure \> 180 mmHg, or diastolic blood pressure \> 110 mmHg at screening.
- ✗Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/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...
- ✗Diabetes mellitus:
- ✗T1DM at the screening visit
See the full criteria
Where Is This Study? (3 UK sites)
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
Liverpool L9 7AL, United Kingdom
Research Site
London E1 1FR, United Kingdom