A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 4 Study of the Efficacy & Safety of Patiromer for Oral Suspension in Combination With Standard of Care Treatment in ED Patients With Hyperkalemia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 115
- 试验地点
- 19
- 主要终点
- The need for additional potassium-lowering medical interventions
研究概览
简要总结
When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.
详细描述
Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of emergent dialysis, there is a need for the development and systematic evaluation of a treatment protocol to shift potassium into the cells followed by the removal of potassium from the body with a potassium binder.. The present study will use a systematic approach to shifting potassium into the cells followed by binding potassium in the gastrointestinal tract in hyperkalemic patients presenting to the ED. Study subjects will receive patiromer or placebo to determine if patiromer reduces the need for additional medical intervention for the management of hyperkalemia in patients initially treated with IV and inhaled therapy in the ED.
Upon enrollment, patiromer will be administered at a dose selected because of its safety and efficacy shown in a pilot study named REDUCE.
Up to 300 patients will be enrolled and followed for up to 14 days, and potassium levels will be measured at pre-determined intervals to assess drug's impact. concomitant medications will be recorded to help determine if study drug helped, not just lower hyperkalemia, but also decrease the number of total interventions needed to reach a normal potassium level.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing
- •Written informed consent obtained.
排除标准
- •Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV antiarrhythmic therapy.
- •Patients who are hemodynamically unstable, defined as mean arterial pressure ≤65 mmHg or heart rate ≤40 beats per minute or ≥125 beats per minute at time of screening
- •Hyperkalemia solely due to overdose on potassium supplements
- •Known bowel obstruction
- •Subjects currently being treated with or having taken potassium binders (e.g., patiromer, sodium or calcium polystyrene sulfonate or sodium zirconium cyclosilicate) in the 7 days prior to baseline
- •Subjects expected to receive dialysis during the first 6 hours of the study treatment period
- •Known hypersensitivity to patiromer or its ingredients
- •Participation in any other investigational device or drug study <30 days prior to screening, or current treatment with other investigational agent(s)
- •Inability to consume the investigational product or, in the opinion of the Investigator unsuitable for study participation
- •Life expectancy of less than 6 months
- •Patients with automatically timed medication orders to control potassium in the ED
- •Patient is known to be pregnant or breastfeeding
- •An employee of investigational site or sponsors
研究组 & 干预措施
Veltassa
3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department
干预措施: Patiromer Powder for Oral Suspension [Veltassa] (Drug)
Placebo
3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department
干预措施: Placebo (Drug)
结局指标
主要结局
The need for additional potassium-lowering medical interventions
时间窗: Duration of patient's emergency department visit, up to 6 hours
Net clinical benefit (mean difference in number of interventions less change in serum potassium)
次要结局
- Potassium level trends after receiving study drug(Up to 24 hours after study drug dose is given)