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
Key facts
- Where
- Badalona, Madrid, Pamplona és Valencia, SpanyolországSee the 4 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Germans Trias i PujolBadalona, SpanyolországNo longer taking part
- Clinica Universidad de NavarraMadrid, SpanyolországNo longer taking part
- Clínica Universidad de navarraPamplona, SpanyolországNo longer taking part
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2025-522407-23-00
- Record updated
- 2026. szeptember 17.
- Original description
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/placebo at reducing albuminuriaRead full original descriptionShow less
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
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/placebo at reducing albuminuria
Inclusion: 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.
Exclusion: 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.