NCT03242967撤回3 期
Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean change in Hb between baseline and the primary evaluation period
研究概览
简要总结
This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
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 in-center hemodialysis (3 times per week) for end-stage kidney disease
- •Currently maintained on ESA therapy
- •Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)
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
Oral tablet
干预措施: Vadadustat (Drug)
Darbepoetin alfa
Active Comparator
subcutaneous or intravenous
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean change in Hb between baseline and the primary evaluation period
时间窗: Baseline visit, Week 36
Mean change in hemoglobin will be evaluated
次要结局
- Mean change in Hb between baseline and the secondary evaluation period(Baseline visit, Week 52)
- Proportion of subjects with mean Hb within the target range during the primary evaluation period(Baseline visit, Week 36)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(52 weeks)
研究者
研究点 (1)
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