EUCTR2012-005180-27-HU进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis - ALPS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- 性别
- All
入选标准
- •Subject is eligible for the study if all of the following apply:
- •- Age = 18 years
- •- Diagnosis of chronic kidney disease, with Kidney Disease Outcomes
- •Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with
- •an eGFR <60 mL/min/1.73 m2 estimated using the abbreviated 4-
- •variable Modification of Diet in Renal Disease (MDRD) equation.
- •- Mean of the three most recent Hb values during the Screening period,
- •obtained at least 4 days apart, must be =10.0 g/dL, with a difference of
- •=1.0 g/dL between the highest and the lowest values.
- •- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =3
- •x upper limit of normal (ULN), and total bilirubin (TBL) =1.5 x ULN.
- •- Body weight of 45.0 kg up to a maximum of 160.0 kg.
- •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 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Subject will be excluded from participation if any of the following apply:
- •- Any ESA treatment within 12 weeks prior to randomization.
- •- More than one dose of IV iron within 12 weeks prior to randomization.
- •- RBC transfusion within 8 weeks prior to randomization.
- •- Chronic inflammatory disease that could impact erythropoiesis.
- •- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a
- •thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12
- •weeks prior to randomization.
- •- Two or more blood pressure values of systolic BP=150 mmHg or
- •diastolic BP=95mmHg within 2 weeks prior to randomization.
研究者
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