Do you suffer from Chronic Kidney Disease (CKD) and Hypertension (HTN)?
This clinical research study is looking at the safety and effectiveness of an investigational medication option for volunteers with chronic kidney disease.
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 of > 50% decline in eGFR, kidney failure, or CV death, in individuals 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 randomization. Thereafter visits will occur approximately every 4 months.
Would you like to take part in CKD 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:
- eGFR ≥ 30 and < 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
- eGFR ≥ 30 and ≤ 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) or UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local or central laboratory values).
- Have a history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
- Are on a stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
- Have:
- Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).
- Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values)
You may not qualify to participate in this study if you:
- Have systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
- Have known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.
- Have serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
- Have type 1 diabetes mellitus
- Have uncontrolled type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
- Display New York Heart Association functional HF class IV at screening.
- Have had any stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
- Have documented history of adrenal insufficiency.
- Have had any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
- Have had any acute kidney injury within 3 months prior to the Screening Visit.
- Have a history of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
- Have had any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
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.
