NCT01235936已完成2 期
Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 79 years of age, inclusive
- •Chronic Kidney Disease Stage 3 or Stage 4
- •Hemoglobin (Hgb) < 10.5 g/dl
- •TSAT > 20% and CBC indicating normocytic red blood cell morphology
排除标准
- •BMI > 40
- •Red blood cell transfusion within 12 weeks.
- •Androgen therapy within the previous 21 days prior to study dosing
- •Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
- •Participants meeting the criteria of ESA resistance within the previous 4 months
- •Individual doses of intravenous iron of 250 mg or larger within the past 21 days
- •AST or ALT >1.8x ULN.
- •Alkaline phosphatase >2x ULN.
- •Total bilirubin >1.5x ULN.
- •Uncontrolled hypertension
- •New York Heart Association Class III or IV congestive heart failure
- •Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
研究组 & 干预措施
AKB-6548
Experimental
干预措施: AKB-6548 (Drug)
结局指标
主要结局
Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
时间窗: Baseline; Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.
次要结局
- Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29(Pre-dose at Day 8, 15, 22 and 29)
- Mean Change From Baseline in Hematocrit on Day 29(Baseline; Day 29)
- Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29(Baseline; Day 29)
- Mean Change From Baseline in Absolute Reticulocyte Count on Day 29(Baseline; Day 29)
- Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29(Baseline; Day 29)
- Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29(Day 29)
- Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29(Day 29)
- Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29(Day 29)
- Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29(Day 29)
- Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29(Day 29)
- Change From Baseline in Ferritin on Day 29(Baseline; Day 29)
- Change From Baseline in Total Iron Binding Capacity on Day 29(Baseline; Day 29)
- Change From Baseline in Transferrin Saturation on Day 29(Baseline; Day 29)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to 2 weeks post 28 days of treatment)
- Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values(Up to 2 weeks post 28 days of treatment)
- Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values(Up to 2 weeks post 28 days of treatment)
- Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings(Up to 2 weeks post 28 days of treatment)
- Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval(Up to 2 weeks post 28 days of treatment)
- Change From Baseline in Iron on Day 29(Baseline; Day 29)
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