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

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ClinicalTrials.gov Identifier: NCT03337477
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Placebo Drug: Sodium Zirconium Cyclosilicate(ZS) Drug: Insulin Drug: Glucose Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
Actual Study Start Date : February 13, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: ZS+insulin+glucose
ZS will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.
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).
Other Name: ZS, ZS-9

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.

Placebo Comparator: Placebo+insulin+glucose
Placebo will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.
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: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337477


Locations
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United States, Alabama
Research Site
Montgomery, Alabama, United States, 36106
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85008
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
Research Site
Detroit, Michigan, United States, 48202
Research Site
Detroit, Michigan, United States, 48235
Research Site
Royal Oak, Michigan, United States, 48073
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63110
United States, New York
Research Site
Stony Brook, New York, United States, 11794
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
Research Site
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Research Site
El Paso, Texas, United States, 79905
Research Site
Houston, Texas, United States, 77030
Denmark
Research Site
Esbjerg, Denmark, 6700
Research Site
Herning, Denmark, 7400
Italy
Research Site
Novara, Italy, 28100
Research Site
Piombino, Italy, 57025
Russian Federation
Research Site
Kemerovo, Russian Federation, 650002
Research Site
Kemerovo, Russian Federation, 650066
Research Site
Moscow, Russian Federation, 115516
Research Site
Moscow, Russian Federation, 121374
Research Site
Perm, Russian Federation, 614990
Research Site
Ryazan, Russian Federation, 390039
Research Site
Saint-Petersburg, Russian Federation, 198205
Research Site
Yaroslavl, Russian Federation, 150062
Research Site
Yekaterinburg, Russian Federation, 620039
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Frank Peacock, MD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] June 13, 2018
Statistical Analysis Plan  [PDF] November 9, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03337477    
Other Study ID Numbers: D9480C00005
2017-003955-50 ( EudraCT Number )
First Posted: November 9, 2017    Key Record Dates
Results First Posted: January 28, 2020
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs