Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension
研究概览
简要总结
Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Eplerenone is a drug that is very effective at improving heart failure and reducing blood pressure in patients that do not require dialysis. There is currently no evidence to tell physicians whether eplerenone would have similar benefits in patients that require dialysis. This evidence can only be reliably generated by performing a large scale study. Before such a study is undertaken, the investigators must determine whether eplerenone will be well tolerated and safe in patients that require dialysis. The investigators will perform an initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe medication to use in a very large, global study that will show whether or not eplerenone reduces important outcomes for patients like death from heart causes.
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
- •Age ≥18 years
- •On hemodialysis >90 days
- •Prescribed target body weight within 1 kg of current for all dialysis sessions within 4 weeks prior to randomization
- •Able to provide written informed consent to participate
排除标准
- •Occurrence of documented clinically important hypotension (systolic blood pressure <90 that required treatment) within 4 weeks of randomization
- •Change in blood pressure medications within 4 weeks prior to randomization
- •Occurrence of pre-dialysis serum potassium >6.0 mmol/L in 4 weeks prior to randomization
- •Currently treated with and cannot withdraw spironolactone or eplerenone due to medical necessity
- •Known allergy or sensitivity to eplerenone
- •Pregnancy
- •Scheduled living related donor renal transplant within the next 6 months
研究组 & 干预措施
Eplerenone
Target of 50 mg/day
干预措施: eplerenone (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension
时间窗: 13 weeks
次要结局
- frequency of serious adverse events(13 weeks)
- fatal and non-fatal vascular events(13 weeks)
- pre-dialysis potassium(13 weeks)
- frequency of hospitalizations for a vascular reason(13 weeks)
- permanent discontinuation of study drug for any reason(13 weeks)
- treatment adherence(13 weeks)