Do you suffer from Chronic Kidney Disease?
This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse.
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.
Would you like to take part in kidney disease research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are of any sex and gender, ≥ 18 years of age at the time of signing the informed consent.
- Have an eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
- Have a UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
- Have a history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
- Are on a 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.
- Have:
- Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
- Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
You may not qualify to participate in this study if you:
- Have systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.
- Have known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening
- Have serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
- Have diabetes mellitus:
- T1DM at the screening visit
- Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
- Have New York Heart Association functional HF class IV at screening
- Use 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
- Have had a 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 randomization.
- Have known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
- Have any documented history of adrenal insufficiency.
- Have had any dialysis (including for acute kidney injury) within 3 months prior to the screening
- Have had any acute kidney injury within 3 months prior to the screening visit.
- Are taking any prohibited concomitant medications
There are other eligibility requirements that the study doctor will review. Only the study doctor can determine whether you are eligible to participate in the study or not.
