A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change in Hemoglobin
研究概览
简要总结
This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •PD patients from the outpatient clinics at MacKay Memorial Hospital
排除标准
- •blood pressure >170/80 on three separate occasions, recent cardiovascular events (such as coronary artery disease, myocardial ischemia, cerebrovascular disease, or peripheral artery disease) within the past 3 months, gastrointestinal bleeding within the past 3 months, and active malignancy.
研究组 & 干预措施
AB sequence
Participants receive intervention A in period 1 followed by intervention B in period 2.
干预措施: Vadadustat (Drug)
BA sequence
Participants receive intervention B in period 1 followed by intervention A in period 2.
干预措施: Vadadustat (Drug)
结局指标
主要结局
Change in Hemoglobin
时间窗: Baseline and end of each 8-week treatment period (up to 5 months).
Within-participant change in hemoglobin during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis.
次要结局
- Quality of Life Score(Baseline and end of each 8-week treatment period (up to 5 months).)
- Inflammatory Markers(Baseline and monthly during the study period, up to 5 months.)
- Iron Metabolism Parameters(Baseline and monthly during the study period, up to 5 months.)