NCT03054350已完成2 期
Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
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
- 60
- 主要终点
- Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Japanese participants ≥20 years of age
- •Receiving chronic maintenance hemodialysis for end-stage kidney disease
- •Hemoglobin (Hb) <10.0 grams per deciliter (g/dL)
排除标准
- •Anemia due to a cause other than chronic kidney disease (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, Dose 1
Experimental
Daily oral dose
干预措施: Vadadustat (Drug)
Vadadustat, Dose 2
Experimental
Daily oral dose
干预措施: Vadadustat (Drug)
Vadadustat, Dose 3
Experimental
Daily oral dose
干预措施: Vadadustat (Drug)
Placebo
Placebo Comparator
Daily oral dose
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period
时间窗: Pre-treatment; Week 6
The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.
次要结局
- Mean Hb Levels at the End of the Primary Efficacy Period(up to Week 6)
- Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period(up to Week 16)
- Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period(Pre-treatment; Week 16)
- Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period(up to Week 16)
- Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Number of Participants Who Required Rescue With Erythropoiesis-Stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16(from Baseline up to Week 16)
- Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4(Week 4, pre-dose)
- Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
- Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
- Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period(up to Week 16)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period(up to Week 6)
- Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period(up to Week 16)
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