EUCTR2018-003819-22-LV进行中（未招募）1 期
Multi-center, blinded, randomized study with aprocitentan in subjects with uncontrolled blood pressure and chronic kidney disease stage 3 or 4. - INSPIRE-CKD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Screening Visit:
- •- Signed and dated informed consent prior to any study-mandated procedure,
- •- Adult male and female subjects,
- •- Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic,
- •- Subjects with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate, eGFR, of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology (CKD-EPI)
- •equation.),
- •- Women of childbearing potential (WOCBP) are eligible only if the following applies:
- •--Negative pregnancy test at the screening visit and at baseline (i.e., end of Run-in period).
- •-- Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation.
- •-- Agree to use highly-effective methods of contraception as described up to at least 30 days after randomized study treatment discontinuation.
- •Run-in period criteria:
- •- Mean trough sitting systolic blood pressure of 140 mmHg or higher measured by automated office blood pressure measurement (AOBPM).
- •Randomization (Baseline) criteria (end of the 2 week run-in period):
- •- Mean trough sitting systolic blood pressure of 140 mmHg or higher measured by AOBPM,
- •- Stable background anti-hypertensive therapy (including a diuretic) since the start of the run-in period,
- •- Estimated glomerular filtration rate (eGFR) equal or above 15 to less than 60 mL/min/1.73 m2,
- •- Subject is at least 80% compliant with study treatment (tablet count) during the run-in period.
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 95
排除标准
- •- Mean sitting systolic blood pressure above 170 mmHg measured by automated office blood pressure measurement (AOBPM),
- •- Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
- •- Change in renal function requiring hospitalization,
- •- Documented eGFR decline of more than 20% in the 3 months prior to the screening visit,
- •- Dialysis in the 3 months before the screening visit,
- •- Planned dialysis or kidney transplant during the course of this study,
- •- Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g,
- •- Known and documented chronic heart failure.
研究者
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