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), Placebo/dapagliflozin (drug)
- How long the study runs
- Study runs about 57 months (dates as stated)
- About the drug or intervention
- Baxdrostat/dapagliflozin — drug: baxdrostat tablet dapagliflozin tablet · Placebo/dapagliflozin — drug: dapagliflozin tablet placebo tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 5,000
- Started
- 2025-03-03
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic kidney disease and hypertension
- • Phase3 - 5,000 participants
- • International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic kidney disease and hypertension
Where?
- • Bradford - Research Site
- • Bristol - Research Site
- • Canterbury - Research Site
- • Cardiff - Research Site
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
More detail
The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
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 (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
Who cannot take part
- ✗Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
- ✗Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- ✗Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the...
- ✗4\. Participants with T1DM will be excluded, except:
- ✗For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who...
See the full criteria
Where Is This Study? (12 UK sites)
Research Site
Bradford BND9 6RJ, United Kingdom
Research Site
Bristol BS105NB, United Kingdom
Research Site
Canterbury CT1 3NG, United Kingdom
Research Site
Cardiff CF14 4XW, United Kingdom
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
Glasgow G51 4TF, United Kingdom
Research Site
Hounslow TW3 3LN, United Kingdom
Research Site
London E1 1FR, United Kingdom
Research Site
London N16 6UH, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
Salford M6 8HD, United Kingdom
Research Site
Swansea SN6 6NL, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
