Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia

Exclusion Criteria

• •1. As judged by the investigator or sponsor, any medical condition (including active, clinically significant infection) that may pose a safety risk to the participant in this study, may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation.
• •2. Myocardial infarction, acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), stroke, seizure, thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 weeks prior to screening visit.
• •3. Severe leucocytosis (\>20 × 109 /L) or thrombocytosis (≥450 × 109 /L) during screening.
• •4. Polycythaemia (haemoglobin \>14 g/dL) during screening.
• •5. Severe constipation, bowel obstruction, post-operative motility disorders.
• •6. Scheduled date for living donor kidney transplant.
• •7. Participants with a life expectancy of less than 6 months.
• •8. Females of childbearing potential, unless using contraception as detailed in the protocol or sexually abstinent.
• •9. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
• •10. Presence of cardiac arrhythmias or conduction defects that require immediate treatment at HCP discretion.
• •11. History of alcohol or drug abuse within 2 years prior to screening visit.
• •12. History of QT prolongation associated with other medications that required discontinuation of that medication.
• •13. Congenital long QT syndrome or QT interval corrected for heart rate (QTc) using Fridericia's method (QTcF) \>550 ms.
• •14. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
• •15. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to screening (see Appendix D), the participant cannot be enrolled in the study.
• •16. Participants treated with SZC, sodium polystyrene sulfonate (SPS: Kayexalate™; Resonium™ A), calcium polystyrene sulfonate (CPS: Calcium Resonium™), or patiromer (Veltassa™) 1 within 4 weeks before screening.
• •17. Participants with a known hypersensitivity or previous anaphylaxis to SZC or any of the excipients of the product.
• •18. Participants unable to take oral SZC. Prior/Concurrent Clinical Study Experience
• •19. Participation in another clinical study with an investigational product administered during the month before screening2 .
• •20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• •21. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• •22. Previous enrolment in the present study.