EUCTR2021-003636-88-BG进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 652
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
- 性别
- All
入选标准
- •Subject must be =18 years of age at the Screening Visit (Visit 1).
- •Body mass index (BMI) must be =19 to <45 kg/m2at the Screening Visit (Visit 1).
- •Subject must have uncontrolled hypertension defined as meeting both of the following criteria:
- •- The subject has a resting seated trough cuff SBP =140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period.
- •- The subject is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3).
- •? The antihypertensive medications must include at least 1 loop, thiazide, or thiazide-like diuretic unless the subject has a documented intolerance to or contraindication for diuretic therapy.
- •? A subject on 1 antihypertensive medication that has been titrated upward as tolerated to a hypertension target dose per local SoC and has been stable during the 4 weeks prior to the Screening Visit (Visit 1) may be enrolled in the study if the subject has a documented history of intolerance to multiple antihypertensive medications.
- •The subject must have Stage 3b (eGFR =30 and =44 mL/min/1.73 m2) or Stage 4 (eGFR =15 and <30 mL/min/1.73 m2) CKD.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 201
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 451
排除标准
- •Subject has a serum potassium level >4.8 mmol/L according to central laboratory results during the Screening or Run-In Periods.
- •Subject has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1).
- •Subject has been hospitalizated for hyperkalemia within the 3 months before the Randomization Visit (Visit 3).
- •Subject was not compliant with taking placebo during the Run-in Period (defined as taking <80% or >120% of planned placebo doses) or the Investigator determines that the subject was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3).
- •Subject has taken a mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1).
- •Subject has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1).
- •Subject has taken a strong CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3).
研究者
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