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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Hyperkalemia

Treatments: Drug: Placebo; Drug: Insulin; Drug: Sodium Zirconium Cyclosilicate(ZS); Drug: Glucose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03337477

D9480C00005

2017-003955-50 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

ZS+insulin+glucose

Experimental group

Description:

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.

Treatment:

Drug: Insulin

Drug: Glucose

Drug: Sodium Zirconium Cyclosilicate(ZS)

Drug: Insulin

Drug: Glucose

Placebo+insulin+glucose

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Insulin

Drug: Glucose

Drug: Insulin

Drug: Glucose