Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

• Status: Recruiting
• Trial end date: 2023-12-22
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining:

• If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital.

• If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

1. Must be 18 years of age or older, at the time of signing the informed consent

2. Admitted to hospital (inpatient care; directly or from ED)

3. With:

• diagnosed stage 3b to 5 CKD And/or

• eGFR < 45 ml/min/1.73 m2 at, or within 3 months of, study screening, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al, 2009).

Note: Race/ethnicity should not be included in CKD-EPI equation calculation.

4. Most recent recorded K+ measurement, either for this admission or at ED visit leading to this admission, should be between 5.5 and 6.5 mmol/L, inclusive

5. Male or female

6. Capable and willing of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

1. Myocardial infarction, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to screening

2. Unable to take oral SZC drug mix

3. Recipient of or scheduled date for living donor kidney transplant

4. With a life expectancy of less than 6 months

5. Any medical condition (including active, clinically significant infection) that, in the opinion of the investigator or sponsor, may pose a safety risk to the participant in this study, which may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation

6. Presence of cardiac arrhythmias or conduction defects that require immediate treatment

7. QT interval corrected by the Fridericia method (QTcF) > 550 msec

8. History of QT prolongation associated with other medications that required discontinuation of that medication

9. Congenital long QT syndrome

10. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participant with atrial fibrillation controlled by medication is permitted.

11. Evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to screening

12. History of alcohol or drug abuse within 2 years prior to screening

13. Ongoing treatment with any K-binder at index hospital admission (initiation of SZC during ED visit immediately preceding the index hospital admission is allowed)

14. Renal replacement therapy, including chronic haemodialysis and peritoneal dialysis

15. Participation in another clinical study with an investigational product (IP) administered during the month before screening. Note: Participant vaccinated with COVID-19 vaccine whilst still under Emergency Use Utilisation will not be excluded from the study.

16. Known hypersensitivity to SZC or any of the excipients of the product

17. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

18. 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

19. Previous randomisation in the present study

20. For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use one of the methods of contraception described hereafter, from the time of signing the informed consent throughout the study and 4 weeks thereafter:

1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal

2. Progestogen-only hormonal contraception associated with inhibition of ovulation:

oral, injectable, implantable

3. Intrauterine device (IUD)

4. Intrauterine hormone-releasing system (IUS)

5. Bilateral tubal occlusion

6. Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success

7. Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.

21. For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.