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

Phase 1

• Conditions: Hyperkalemia requiring urgent therapy (serum potassium more than or equal to 5.8mmol/L).; MedDRA version: 20.1 Level: PT Classification code 10020646 Term: Hyperkalaemia System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003955-50-DK
• Lead Sponsor: AstraZeneca, AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

• = 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified