EUCTR2012-004179-38-NL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of different oral doses of BAY 94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy - ARTS-D
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 823
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
- •Men and women aged 18 years and older.
- •Subjects with type 2 diabetes mellitus
- •Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:
- •- Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m2 (CKD-EPI) or
- •- Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m2 (CKD-EPI)
- •Subjects with at least the minimal dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit; subjects with an eGFR of 30-45 mL/min/1.73 m2 (CKD-EPI) must also be treated with a non-potassium sparing diuretic at the screening visit and without any adjustments to this therapy for at least 4 weeks prior to the screening visit
- •- Serum potassium
- •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 670
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 670
排除标准
- •Non-diabetic renal disease (confirmed by biopsy)
- •Known bilateral clinically relevant renal artery stenosis (>75%)
- •Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
- •Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
- •Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the run-in visit
研究者
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