A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
ENERGIZE
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
2 other identifiers
interventional
70
4 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2018
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
November 9, 2017
CompletedStudy Start
First participant enrolled
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedResults Posted
Study results publicly available
January 28, 2020
CompletedJanuary 28, 2020
January 1, 2020
10 months
October 23, 2017
December 11, 2019
January 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
Baseline to 4h potassium meansurements.
The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo
Baseline to 4h potassium meansurements.
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.
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.
The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.
Baseline to 4h potassium meansurements.
- +1 more secondary outcomes
Study Arms (2)
ZS+insulin+glucose
EXPERIMENTALZS 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.
Placebo+insulin+glucose
PLACEBO COMPARATORPlacebo 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.
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).
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Potassium ≥5.8 mmol/L
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Montgomery, Alabama, 36106, United States
Research Site
Phoenix, Arizona, 85008, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Detroit, Michigan, 48235, United States
Research Site
Royal Oak, Michigan, 48073, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Stony Brook, New York, 11794, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Winston-Salem, North Carolina, 27157, United States
Research Site
El Paso, Texas, 79905, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Esbjerg, 6700, Denmark
Research Site
Herning, 7400, Denmark
Research Site
Novara, 28100, Italy
Research Site
Piombino, 57025, Italy
Research Site
Kemerovo, 650002, Russia
Research Site
Kemerovo, 650066, Russia
Research Site
Moscow, 115516, Russia
Research Site
Moscow, 121374, Russia
Research Site
Perm, 614990, Russia
Research Site
Ryazan, 390039, Russia
Research Site
Saint Petersburg, 198205, Russia
Research Site
Yaroslavl, 150062, Russia
Research Site
Yekaterinburg, 620039, Russia
Related Publications (1)
Peacock WF, Rafique Z, Vishnevskiy K, Michelson E, Vishneva E, Zvereva T, Nahra R, Li D, Miller J. Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE). Acad Emerg Med. 2020 Jun;27(6):475-486. doi: 10.1111/acem.13954. Epub 2020 Mar 28.
PMID: 32149451DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Recruitment was stopped at 70 patients randomized instead of 132, as initially planned.
Results Point of Contact
- Title
- Study Information Center
- Organization
- AstraZeneca Clinical
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Peacock, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2017
First Posted
November 9, 2017
Study Start
February 13, 2018
Primary Completion
December 21, 2018
Study Completion
December 21, 2018
Last Updated
January 28, 2020
Results First Posted
January 28, 2020
Record last verified: 2020-01