2023-506460-14-00招募中3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,310
- 试验地点
- 209
- 主要终点
- Time to the first occurrence of any of the components of the composite of: 1. ≥ 50% sustained decline in eGFR 2. 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) 3. CV death
研究概览
简要总结
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, or CV death.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- •Participants with (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: - UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory value), or - UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or - UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only). (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND: - UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or - UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
- •Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at 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: a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values). b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values).
排除标准
- •Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
- •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).
- •Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- •Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
- •Participants with T1DM will be excluded, except: a) 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. 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.
- •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.
结局指标
主要结局
Time to the first occurrence of any of the components of the composite of: 1. ≥ 50% sustained decline in eGFR 2. 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) 3. CV death
Time to the first occurrence of any of the components of the composite of: 1. ≥ 50% sustained decline in eGFR 2. 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) 3. CV death
次要结局
- Change from baseline in UACR.
- Change from baseline in mean SBP.
- Time to the first occurrence of any of the components of the composite of: • CV death • HF with and without hospitalisation • MI • Stroke
- CV death.
- Death.
研究者
Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (209)
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