Last updated 25 days ago
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
5000 patients around the world
Available in Chile, Peru, Brazil, Argentina, Mexico
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 endpoint of ≥ 50% sustained decline in eGFR, kidney
failure, HF events, or CV death in participants 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 randomisation.
Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of primary
endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised
participants including any participants who have prematurely discontinued study
intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be
extended by AstraZeneca.
In case of premature discontinuation of blinded study intervention, participants will
continue in the study and receive dapagliflozin 10 mg, unless the participant meets
dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be
administered without dapagliflozin: baxdrostat/placebo should be interrupted if
dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if
dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is
permanently discontinued. If study intervention is temporarily or permanently
discontinued, the participant should remain in the study, and it is important that the
scheduled study visits (including the PTDV for participants with permanent
discontinuation of study intervention) and data collection continue according to the
study protocol until the SCV.
AstraZeneca
3Research sites
5000Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Arterial hypertension
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 < 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).Participants with 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).Participants with 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.Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.Participants with serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).Participants with serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values).
- Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).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.Documented history of adrenal insufficiency.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).Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Grupo Sur
Recruiting
StudyBaxDuo-Pacific
SponsorAstraZeneca
Study typeInterventional
Conditions
Chronic kidney diseaseArterial hypertension
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06742723
