The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 29
- 主要终点
- Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).
详细描述
Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.
All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.
The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.
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
- •Potassium concentration > 5.0 mEq/L from two blood draws at Screening
- •Stable RAASi medication, if taking
- •Medications taken on a chronic basis are given once daily or twice daily
- •Informed consent given
排除标准
- •Expected need for dialysis
- •Major organ transplant
- •History of conditions associated with pseudohyperkalemia
- •History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
- •Cancer or unstable medical condition
研究组 & 干预措施
Group 1 - Dosing Without Food
Patiromer dosing without food
干预措施: patiromer (Drug)
Group 2 - Dosing With Food
Patiromer dosing with food
干预措施: patiromer (Drug)
结局指标
主要结局
Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
时间窗: 21 to 28 Days
次要结局
- Mean Change in Serum Potassium From Baseline to Week 4(Baseline to Day 28)