Hyperkalemia
Conditions
Interventions
investigational material(s)
Generic name etc : Sodium Zirconium Cyclosilicate (ZS)
INN of investigational material : -
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administra
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female or male aged 18 years or more at screening Visit 1. For patients aged 5.4 mmol/L after long inter-dialytic interval and >5.0 mmol/L after one short inter-dialytic interval during screening (as assessed by central lab). 6. Prescribed dialysate K concentration 3 mmol/L or less during screening 7. Sustained Qb 200 ml/min or more and spKt/V 1.2 or more on stable hemodialysis/hemodiafltration prescription during screening with prescription (time, dialyzer, blood flow [Qb], dialysis flow rate [Qd] and bicarbonate concentration expected to remain unchanged during study 8. Heparin dose (if used) must be stable during screening and expected to be stable during the study 9. Subjects must be receiving dietary counseling appropriate for ESRD patients treated with hemodialysis/hemodiafiltration as per local guidelines, which includes dietary potassium restriction.
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, including ZS Pharma staff and/or staff at the study site) 2. Hemoglobin 20 X 109/L) or thrombocytosis (450 X 109/L or more) 9. Polycythemia (Hb >14 g/dL) 10. Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization 11. Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug 12. Patients unable to take oral ZS drug mix 13. Scheduled date for living donor kidney transplant 14. Patients with a life expectancy of less than 6 months 15. Female patients who are pregnant or breastfeeding 16. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence. 17. Known hypersensitivity or previous anaphylaxis to ZS or to components thereof 18. Participation in another clinical study with an investigational product during the last 1 month before screening 19. Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation 20. Presence of cardiac arrhythmias or conduction defects that require immediate treatment 21. History of alcohol or drug abuse within 2 years prior to randomization 22. Previous randomization in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety - | — |
Countries
Europe, Japan, North America
Outcome results
None listed