A Phase III, Randomised, Double-Blind, Active-Controlled 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 - D6972C00003

Astrazeneca AB0 个研究点目标入组 2,500 人开始时间: 2024年1月31日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Astrazeneca AB
入组人数: 2,500

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•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

排除标准

•Medical Conditions 1. 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 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., 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).

研究者

发起方

Astrazeneca AB

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