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A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Kidney Disease and Hypertension
Date of first enrollment	03/03/2025
Target sample size	5000
Countries of recruitment	Argentina,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Peru,Japan,United States,Japan,Belguim,Japan,Bulgaria,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Romania,Japan,Serbia,Japan,Slovakia,Japan,Spain,Japan,Sweden,Japan,Ukraine,Japan,United Kingdom,Japan,China,Japan,Australia,Japan,Egypt,Japan
Study type	Interventional
Intervention(s)	Run-in Period: Participants who are not on SGLT2i at screening will receive a run-in intervention with dapagliflozin. Double-blind period: Participantsl receive a baxdrostat and dapagliflozin or placebo matching baxdrostat and dapagliflozin.

Outcome(s)

Primary Outcome

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of 50% or more sustained decline in eGFR (estimated glomerular filtration rate) [Time Frame: Up to 41 months] - Time to the first occurrence of any of the components of the composite of 50% or more sustained decline in eGFR (estimated glomerular filtration rate). To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of kidney failure [Time Frame: Up to 41 months] - Time to the first occurrence of any of the components of the composite of: - Onset of kidney failure: - Sustained eGFR < 15 mL/min/1.73 m2 or - Chronic dialysis treatment or - Receiving a kidney transplant or - Death with a renal primary cause (death due to kidney failure when dialysis is not given) To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death. [Time Frame: Up to 41 months] - Time to the first occurrence of any of the components of the composite of CV (cardiovascular) death

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 130age old
Gender	Both
Include criteria	1. Participants of any sex and gender must be 18 years of age or more at the time of signing the informed consent. 2. Participants with: a. eGFR 30 or more and < 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR 30 mg/g (3.39 mg/mmol) or more and < 500 mg/g (56.5 mg/mmol) (central laboratory values only), or b. eGFR 30 or more and 75 mL/min/1.73 m2 (local or central laboratory values) or less AND UACR 500 mg/g (56.5 mg/mmol) or more and 5000 mg/g (565 mg/mmol) or less or UPCR 700 mg/g (79 mg/mmol) or more and 7000 mg/g (790 mg/mmol) (local or central laboratory values) or less. 3. 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) or more and 120 mmHg or more at the Randomisation Visit. 4. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit. 5. Participants with: a. Serum or plasma potassium 3.0 or more and 4.8 mmol/L or less if eGFR 45 mL/min/1.73 m2 (local or central laboratory values) or more. b. Serum or plasma potassium 3.0 or more and 4.5 mmol/L or less if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values).
Exclude criteria	1. Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening. 2. Known hyperkalaemia, defined as potassium of 5.5 mmol/L or more within 3 months prior to screening. 3. Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit). 4. T1DM: a. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that E145period, and who have experience with ketone monitoring are eligible for inclusion. b. 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. 5 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). 6 New York Heart Association functional HF class IV at screening. 7 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. 8 Documented history of adrenal insufficiency. 9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit. 10 Any acute kidney injury within 3 months prior to the Screening Visit. 11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant). 12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).