Reduce Incidence of Pre-Dialysis Hyperkalaemia with Sodium Zirconium Cyclosilicate in Chinese Subjects - DIALIZE China

Exclusion Criteria

• 1. Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic / thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to randomization.
• 2. Pseudohyperkalaemia secondary to haemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable).
• 3. Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization.
• 4. Presence of cardiac arrhythmias or conduction defects that require immediate treatment.
• 5. Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation.
• 6. History of QT prolongation associated with other medications that required discontinuation of that medication; congenital long QT syndrome or QTc(f) > 550 msec; uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication or with transient atrial fibrillation associated with dialysis or peridialytic period are permitted.
• 7. Subjects treated with sodium polystyrene sulfonate (e.g. SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS, Resonium calcium) or patiromer (Veltassa) within 7 days before screening or anticipated in requiring any of these agents during the study.
• 8. Participation in another clinical study with an investigational product administered in the last 1 month before screening.
• 9. Haemoglobin < 9 g/dL on screening (as assessed on Visit 1).
• 10. Laboratory diagnosis of hypokalaemia (K < 3.5 mmol/L), hypocalcemia (Ca < 8.2 mg/d or albumin-corrected Ca < 8.0 mg/dL if the latter is used in local practice), hypomagnesemia (Mg < 1.7 mg/dL) or severe acidosis (serum bicarbonate 16 mEq/L or less) in the 4 weeks preceding randomization.
• 11. Severe leukocytosis (> 20 × 109/L) or thrombocytosis (≥ 450 × 109/L) during screening.
• 12. Polycythaemia (Hb > 14 g/dL) during screening.
• 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• 14. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
• 15. Previous randomisation in the present study.
• 16. For women only - currently pregnant (confirmed with positive pregnancy test or uterine ultrasound if pregnancy test is questionable) or breast-feeding.
• 17. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
• 18. Lack of compliance with haemodialysis prescription (both number and duration of treatments) during the two-week period preceding screening (100% compliance required).
• 19. Subjects unable to take investigational product drug mix.
• 20. Scheduled date for living donor kidney transplant.
• 21. Subjects with a life expectancy of less than 6 months.
• 22. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
• 23. History of alcohol or drug abuse within 2 years prior to randomization.