2023-506457-38-00RecruitingPhase 3
A Phase III, Randomised, Double-Blind, Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Astrazeneca AB
- Enrollment
- 675
- Locations
- 183
- Primary Endpoint
- Change from baseline in eGFR to post treatment.
Study Overview
Brief Summary
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR ( eGFR estimated glomerular filtration rate) over time.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
- •Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
- •Urine albumin creatinine ratio > 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 tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
- •Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR: o for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.5 and ≤ 4.8 mmol/L at the Screening Visit o for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.5 and ≤ 4.5 mmol/L at the Screening Visit
Exclusion Criteria
- •Medical Conditions
- •Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
- •History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
- •Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit
- •Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), 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.
- •Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- •Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
- •Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at Screening.
- •New York Heart Association functional HF class IV at screening.
- •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.
- •Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
- •Any acute kidney injury within 3 months prior to the Screening Visit
- •History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
Outcomes
Primary Outcomes
Change from baseline in eGFR to post treatment.
Change from baseline in eGFR to post treatment.
Secondary Outcomes
- 1. Change from baseline in UACR.
- 2. Change from baseline in systolic BP (blood pressure).
- 3. Kidney hierarchical composite endpoint.* *Defined as the most severe outcome of the following: 1. Death; 2. KFRT (chronic dialysis or kidney transplant); 3. Sustained GFR < 15 mL/min/1.73 m2; 4. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6. individual change from baseline to post-treatment eGFR if none of the outcomes occurred.
- 4. Change in eGFR from following randomisation.
- 5. Time to the first occurrence of any of the components of the composite of: 1) CV death 2) HF with and without hospitalisation 3) MI 4) Stroke
Investigators
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
Study Sites (183)
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