EUCTR2017-003955-50-DK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
AstraZeneca, AB0 个研究点目标入组 132 人开始时间: 2017年11月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
入选标准
- •= 18 years of age at the time of signing the informed consent form.
- •S-K = 5.8 mmol/L, as determined using an i-STAT device. Patients with S-K 5.8 or 5.9 mmol/L can be included only if treatment of the patient with insulin and glucose is in accordance with the local standard of care. S-K measured by local laboratory prior to insulin administration may replace S-K measured by i-STAT for assessment against this inclusion criterion for patients having received insulin before signing the informed consent form.
- •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, but is not limited to hyperkalaemia reasonably likely to be caused by physical injury, intoxication, pre-renal kidney failure, substance abuse, diabetic ketoacidosis and rhabdomyolysis.
- •Presence of any other acute or chronic medical condition which, in the opinion of the investigator, places the patient at undue risk due to the severity of illness or potentially jeopardizes patients' ability to follow study procedures in the acute setting. Patients having any acute or chronic medical condition other than hyperkalaemia that would alone require immediate treatment in the hospital setting at Visit 1. are not eligible for the study.
- •Dialysis session expected within 4h after randomization.
- •Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1. with exception of patients meeting the following criteria:
- •- Treated with no more than one course of insulin since arriving at the hospital.
- •- S-K measured by i-STAT device or local laboratory prior to administration of insulin. S-K must have met Inclusion criterion 4.
- •- Reasonably likely to randomize, have screening and 0h assessments done, and dose the patient with ZS/placebo within 30 minutes of the start of administration of insulin.
研究者
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