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

Hyperkalemia Clinical Trial

— ENERGIZE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337477
• Other study ID #: D9480C00005
• Secondary ID: 2017-003955-50
• Status: Completed
• Phase: Phase 2
• Start date: February 13, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: January 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

= 18 years of age

Potassium =5.8 mmol/L

Exclusion Criteria:

Possible pseudohyperkalaemia

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.

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.

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

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).
• 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).
• Insulin
Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
• Glucose
Glucose 25g administered IV <15 minutes before the insulin.
• Insulin
Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
• Glucose
Glucose 25g administered IV <15 minutes before the insulin.

Locations

Country	Name	City	State
Denmark	Research Site	Esbjerg
Denmark	Research Site	Herning
Italy	Research Site	Novara
Italy	Research Site	Piombino
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Yaroslavl
Russian Federation	Research Site	Yekaterinburg
United States	Research Site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	El Paso	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Montgomery	Alabama
United States	Research Site	Phoenix	Arizona
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Stony Brook	New York
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Denmark,  Italy,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo	The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.	Baseline to 4h potassium measurements.
Secondary	Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment	Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders.	Baseline to 4h potassium meansurements.
Secondary	The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo	Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing	Baseline to 4h potassium meansurements.
Secondary	The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo		Baseline to 4h potassium meansurements.
Secondary	The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo		Baseline to 4h potassium meansurements.
Secondary	The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.	Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K.	Baseline to 4h potassium meansurements.
Secondary	Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo	The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.	Baseline to 2h potassium measurements.

External Links

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