A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Sodium Zirconium Cyclosilicate(ZS) (Drug)
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.
Intervention: Placebo (Drug)
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.
Intervention: Insulin (Drug)
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.
Intervention: Insulin (Drug)
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.
Intervention: Glucose (Drug)
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.
Intervention: Glucose (Drug)
Outcomes
Primary Outcomes
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
- 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.)
- Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo(Baseline to 2h potassium measurements.)