A study to assess whether ZS (Sodium Zirconium Cyclosilicate) added to standard of care¿ (insulin and glucose) is effective in treating elevated blood potassium concentratio
- Conditions
- Hyperkalemia requiring urgent therapy (serum potassium more than or equal to 6.0).MedDRA version: 21.1Level: PTClassification code 10020646Term: HyperkalaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003955-50-IT
- Lead Sponsor
- ASTRAZENECA SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
• = 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method