Phase 2 N=70 Randomized Triple-blind Treatment

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

Hyperkalemia

Bottom Line

View on ClinicalTrials.gov: NCT03337477 ↗

Enrolled (actual)

Serious AEs

6.5%

Results posted

Jan 2020

Primary outcome: Primary: Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo — -0.41; -0.27 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Sodium Zirconium Cyclosilicate(ZS) (Drug); Insulin (Drug); Glucose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo	-0.41; -0.27	—
SECONDARY 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	0.063; 0.056	—
SECONDARY The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo	0.156; 0.139; 0.125; 0.056; 0.063; 0.056	—
SECONDARY The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo	0.313; 0.306; 0.375; 0.167; 0.156; 0.139	—
SECONDARY The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo	0.656; 0.611; 0.625; 0.472; 0.469; 0.361	—
SECONDARY The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.	0.156; 0.306	—
SECONDARY Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo	-0.67; -0.67; -0.72; -0.36	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03337477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.