NCT03337477

A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Placebo	Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).
DRUG	Sodium Zirconium Cyclosilicate(ZS)	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).
DRUG	Insulin	Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
DRUG	Glucose	Glucose 25g administered IV \<15 minutes before the insulin.
DRUG	Insulin	Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
DRUG	Glucose	Glucose 25g administered IV \<15 minutes before the insulin.

Timeline

• Start date: 2018-02-13
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2017-11-09
• Last updated: 2020-01-28
• Results posted: 2020-01-28

Locations

25 sites across 4 countries: United States, Denmark, Italy, Russia

Regulatory

• FDA-regulated drug study