NCT03140722终止2 期
Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
研究概览
简要总结
This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥18 years of age
- •Receiving chronic maintenance hemodialysis for end-stage kidney disease
- •Currently receiving epoetin alfa for anemia
- •Hb between 8.5 and 10.0 g/dL during screening
排除标准
- •Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
- •Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- •Red blood cell transfusion within 4 weeks prior to or during screening
- •Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
研究组 & 干预措施
vadadustat
Experimental
Vadadustat daily oral dose, adjustable based on Hb level
干预措施: vadadustat (Drug)
epoetin alfa
Active Comparator
Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study
干预措施: epoetin alfa (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
时间窗: Baseline; up to 20 weeks
次要结局
- Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period(Baseline; up to 20 weeks)
- Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period(Baseline; up to 20 weeks)
- Number of Participants Receiving Epoetin Alfa Rescue(up to 20 weeks)
- Number of Participants Receiving Red Blood Cell Transfusion(up to 20 weeks)
- Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor(up to 20 weeks)
- Mean Weekly Dose of Intravenous Elemental Iron Administered(up to 20 weeks)
- Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)(up to 20 weeks)
- Number of Participants Utilizing Resources(up to 20 weeks)
- Number of Participants With Treatment-emergent Adverse Events(up to 24 weeks)
研究者
研究点 (1)
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