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Completed

NCT Number: NCT03337477

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

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.

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Key information

Conditions

Hyperkalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Esbjerg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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)

Drug

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).

Other names: ZS, ZS-9

Insulin

Drug

Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.

Glucose

Drug

Glucose 25g administered IV <15 minutes before the insulin.

Primary outcomes

  1. Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo

    Time frame: Baseline to 4h potassium measurements.

    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.

Secondary outcomes

  1. 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

    Time frame: Baseline to 4h potassium meansurements.

    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.

  2. The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo

    Time frame: Baseline to 4h potassium meansurements.

    Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing

  3. The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo

    Time frame: Baseline to 4h potassium meansurements.

  4. The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo

    Time frame: Baseline to 4h potassium meansurements.

  5. The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.

    Time frame: Baseline to 4h potassium meansurements.

    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.

  6. Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo

    Time frame: Baseline to 2h potassium measurements.

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ENERGIZE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2017
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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