An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Serum Potassium (Day 1 to Day 8)
研究概览
简要总结
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
详细描述
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.
This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L
- •Adequately dialyzed (Kt/V ≥ 1.2)
排除标准
- •History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery.
- •Severe constipation or irregular bowel habits.
- •Unable to consume or tolerate the study-specific diet.
研究组 & 干预措施
patiromer
干预措施: patiromer (Drug)
结局指标
主要结局
Change in Serum Potassium (Day 1 to Day 8)
时间窗: Day 1 and Day 8
Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)
时间窗: Day -7 Through Day -1 and Day 1 Through Day 7
次要结局
未报告次要终点