Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average
研究概览
简要总结
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 79 years inclusive
- •Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
- •Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron
排除标准
- •Body mass index >44.0 kilograms per meter squared (kg/m^2)
- •Transfusion within 8 weeks prior to Screening
- •Alanine transaminase or total bilirubin >1.25x ULN
- •Uncontrolled hypertension
- •Class III or IV congestive heart failure
- •Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening
研究组 & 干预措施
AKB-6548, starting dose 1
干预措施: AKB-6548 (Drug)
AKB-6548, starting dose 2
干预措施: AKB-6548 (Drug)
AKB-6548, starting dose 3
干预措施: AKB-6548 (Drug)
结局指标
主要结局
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average
时间窗: Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8
Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.
Change From Pre-dose Average in Hgb Level to The End-of-study Average
时间窗: Pre-dose, Week 15, and Week 16
Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Change From Mid-study Average in Hgb Level to The End-of-study Average
时间窗: Week 7, Week 8, Week 15, and Week 16
Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
次要结局
- Change From Baseline in Absolute Reticulocyte Count(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Transferrin Saturation (TSAT)(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite(Pre-dialysis and post-dialysis on Week 2 and Week 16)
- Change From Baseline in Hematocrit(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Red Blood Cell (RBC) Count(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Percent Reticulocyte Count(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Ferritin(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Hepcidin(Baseline, Week 8, and Week 16)
- Change From Baseline in Total Iron-Binding Capacity (TIBC)(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Iron(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Change From Baseline in Reticulocyte Hgb Content(Baseline, Week 2, Week 4, Week 8, and Week 16)
- Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy(Up to Week 16)
- Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings(Up to Week 20)
- Change From Baseline in Hgb(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Number of Participants Who Received Blood Transfusion Rescue Therapy(Up to Week 16)
- Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite(Pre-dialysis and post-dialysis on Week 2 and Week 16)
- Number of Participants With Clinically Significant Changes From Baseline in Vital Signs(Up to Week 20)
- Mean Plasma Concentrations of Vadadustat(Pre-dialysis and post-dialysis on Week 2 and Week 16)
- Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to Week 20)
- Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values(Up to Week 20)