Status:
ACTIVE_NOT_RECRUITING
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Kidney Disease and Hypertension
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflo...
Eligibility Criteria
Inclusion
- 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:
- for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
- for participants with screening eGFR \< 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit
Exclusion
- Systolic blood pressure \> 180 mmHg, or DBP \> 110 mmHg at 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.
- Diabetes mellitus:
- (a) T1DM at Screening Visit: (i) For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
- (ii) For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
- (b) Uncontrolled T2DM at screening: HbA1C \> 10.5% (\> 91 mmol/mol).
- 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).
- 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 1.
- 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.
Key Trial Info
Start Date :
March 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2028
Estimated Enrollment :
2455 Patients enrolled
Trial Details
Trial ID
NCT06268873
Start Date
March 29 2024
End Date
March 2 2028
Last Update
October 28 2025
Active Locations (564)
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1
Research Site
Fairhope, Alabama, United States, 36532
2
Research Site
Phoenix, Arizona, United States, 85016
3
Research Site
Surprise, Arizona, United States, 85374
4
Research Site
Tucson, Arizona, United States, 85710