At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
In Brief
A Phase 2 clinical trial evaluating Placebo, Sodium Zirconium Cyclosilicate(ZS), and 2 other interventions for Hyperkalemia. Completed, enrolled 70 participants across 25 sites in 4 countries.
Detailed Summary
The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with insulin and glucose.
Study Details
Timeline
Interventions
Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).
Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).
Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
Glucose 25g administered IV \<15 minutes before the insulin.
Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
Glucose 25g administered IV \<15 minutes before the insulin.