Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,200
- 试验地点
- 5
- 主要终点
- Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.
研究概览
简要总结
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
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
- •Adult patients greater than or equal to 18 years of age.
- •Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
- •Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
排除标准
- •Contraindication to receive vadadustat or any of its known constituents per USPI.
- •Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
- •Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
- •Pregnant at time of consent (per subject self-report).
研究组 & 干预措施
Vadadustat
Vadadustat, 300 mg tablets, administered orally three times per week
干预措施: Vadadustat (Drug)
Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)
Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care
干预措施: Erythropoiesis Stimulating Agent (Drug)
结局指标
主要结局
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.
时间窗: 18 months
The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization.
次要结局
- All-cause hospitalization(18 months)
- All-cause mortality(18 months)