EUCTR2017-003955-50-IT进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE) - ENERGIZE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •= 18 years of age at the time of signing the informed consent form.
- •Whole blood potassium =6.0 mmol/L, as determined using an i-STAT device.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •Possible pseudohyperkalaemia as assessed by the investigator, e.g. secondary to hemolyzed blood specimen.
- •Hyperkalaemia caused by any condition for which a therapy directed against the underlying cause of hyperkalaemia would be a better treatment option than treatment with insulin and glucose. This includes hyperkalaemia reasonably likely to be caused by physical injury, intoxication, pre-renal kidney failure, substance abuse, diabetic ketoacidosis, and rhabdomyolysis.
- •Dialysis session scheduled or anticipated within 4h after randomization.
- •Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1.
研究者
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