Phase 4
N=186
Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
Hyperkalaemia · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT05347693 ↗Enrolled (actual)
186
Serious AEs
19.4%
Results posted
Nov 2025
Primary outcome: Primary: Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge — 21; 25; 47; 44 Number of participants — p=0.558
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium Zirconium Cyclosilicate (SZC) (Drug); Local standard of care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge |
21; 25; 47; 44 | 0.558 |
| SECONDARY Time to First Occurrence of Any Component of All-cause Hospital Admissions or ED Visits With HK as a Contributing Factor, or All-cause Death, or Use of Rescue Therapy for HK at Any Time Post-discharge up to 180 Days |
136; NA | 0.743 |
| SECONDARY Time to First Occurrence of Any Component of All-cause Hospital Admission or ED Visit With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days |
NA; NA | 0.951 |
| SECONDARY Number of All-cause Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days |
0.7; 0.6 | 0.152 |
| SECONDARY Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days |
NA; NA | 0.515 |
| SECONDARY Time to First Occurrence of Hospital Admission or ED Visit, Both With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days |
NA; NA | 0.258 |
| SECONDARY Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days |
0.1; 0.1 | 0.239 |
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.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years of age or older, at the time of signing the informed consent
- Admitted to hospital (inpatient care; directly or from ED)
- With:
- Diagnosed CKD (any stage) or
- eGFR 550 msec
- History of QT prolongation associated with other medications that required discontinuation of that medication
- Congenital long QT syndrome
- Clinically significant arrythmias as judged by the investigator
- Ongoing treatment with SZC or patiromer before current ED visit/hospital admission (ongoing treatment with other K-binders before current ED visit/hospital admission is allowed).
Note: Initiation of any SZC or patiromer during the current ED visit/hospitalisation preceding enrolment is allowed.
- Chronic haemodialysis or peritoneal dialysis or the recipient of or scheduled date for a kidney transplant. Note: Emergency/unscheduled haemodialysis to treat HK during the current ED visit/hospitalisation preceding enrolment is allowed.
- Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
- Known hypersensitivity to SZC or any of the excipients of the product
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- 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
- Previous randomisation in the present study
- 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, or who are not stable on the contraception method for the last one month, from the time of signing the informed consent throughout the study and 7 days after the last dose: (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (c) Intrauterine device (d) Intrauterine hormone-releasing system (e) Bilateral tubal occlusion (f) 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 (g) 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.
- For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.
Data sourced from ClinicalTrials.gov (NCT05347693). 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.