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CompletedNCT05347693CONTINUITYUpdated Nov 28, 2025Results posted

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

A Phase 4 interventional study of Sodium Zirconium Cyclosilicate (SZC) and Local standard of care in Hyperkalaemia and Chronic Kidney Disease, sponsored by AstraZeneca. Completed at 28 sites in 6 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
All
01

Study 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.
Read the detailed description

This is a Phase 4, randomised, controlled, open-label, parallel-group, multicentre study in participants with CKD treated for HK whilst in hospital.

  • Participants from 30 to 50 sites in 4 to 7 countries will be screened for enrolment. In total, up to a maximum of 163 participants will be enrolled, resulting in approximately 130 participants discharged and randomised and 104 evaluable participants (52 per arm).
  • The study plans to enrol approximately equal numbers of participants with mild HK (K+ between > 5.0 and ≤ 5.5 mmol/L) and with moderate/severe HK (K+ between > 5.5 and ≤ 6.5 mmol/L), with a minimum of 30% of the enrolled participants in either group.

  • During the in-hospital phase, participants will be treated with SZC as per local label, starting at baseline and based on local K+ measurement obtained within 24 hours of treatment initiation:).

    • Participants with HK (K+ between > 5.0 and ≤ 6.5 mmol/L):

      1. stop current K-binder if any
      2. start SZC correction dose (note: participants currently on SZC should continue SZC correction dose, up to 72 hours).
    • Participants currently receiving any treatment for the current episode of HK and are already NK at baseline (K+ ≤ 5.0 mmol/L): 1) stop any current K-binder, 2) start SZC maintenance dose (note: participants currently on SZC maintenance dose should continue SZC maintenance dose).
    • All treatment decisions, including modification of the ongoing therapy for HK must be based on the investigator's medical judgement of the participant's best interest.

  • At discharge, NK participants who have been treated with SZC for between 1 and 21 days whilst in hospital and are started on SZC maintenance dose will be randomised in a 1:1 ratio to one of the following arms:

    • Arm A: Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase
    • Arm B: Participants discharged with SoC, as per local practice, to manage HK until the end of study. Note: Participants intended to be discharged with a K+ binder (as per the site routine medical practice) will not be randomised and will be discontinued from the study. Still, participants randomised into Arm B may have a K-binder prescribed at Day 7 post-discharge, (or after Day 7 post-discharge), to treat confirmed HK or in case there is an increase in K+ level since discharge that, in the investigator's opinion, requires therapy.
  • The total duration of the study for each participant will be up to approximately 6 months.
  • Study visit schedule is as follows:

In-hospital phase: - The screening visit will occur while the participant is at the hospital (up to 21 days before discharge; medical monitor's approval may be sought for allowing longer duration hospital stays for specific participants) in order to check eligibility criteria

  • Inpatient phase: o The baseline visit (can occur the same day as the screening visit) where treatment with SZC will be initiated

    o The discharge visit, 1 to 20 days after baseline; medical monitor's approval may be sought for allowing longer duration hospital stays for specific participants). Randomisation will occur at day of discharge.

  • Outpatient phase: - Visits will occur at 7, 30, 60, 90, 120, 150, and 180 (EOT, End of Trial) days after randomisation. Only visits at 7, 90 and 180 days after randomisation will be on-site visits, the remaining being telephone visits. If dose titration occurs at any time during the outpatient phase, unscheduled dispensation visits will be performed.

Follow-up phase: - A follow-up on-site visit (end of study visit) will occur approximately 7 days after EOT. • Data will be collected at on-site visits, via telephone visits and medical chart reviews.

  • An adjudication committee will be involved in the study.
02

Conditions studied

  • Hyperkalaemia
  • Chronic Kidney Disease

Keywords

  • sodium zirconium cyclosilicate
  • Hyperkalaemia after discharge at the hospital
03

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

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:

    1. Diagnosed CKD (any stage) or
    2. eGFR \< 90 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.

  • Local laboratory K+ measurement within 24 hours of baseline visit (visit 2), where result is either:
  • Hyperkalaemic as defined by site's local practice and K+ ≤ 6.5 mmol/L.
  • Or, normokalaemic: K+ between ≥ 3.5 and ≤ 5.0 mmol/L, where patient started and is receiving treatment for this episode of HK
  • Male or female
  • 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

Exclusion Criteria:

  • Hospitalisation for an acute cardiovascular event within 12 weeks prior to screening
  • Unable to take oral SZC drug mix
  • With a life expectancy of less than 6 months
  • Any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion
  • QT interval corrected by the Fridericia method (QTcF) > 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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    Sodium Zirconium Cyclosilicate (SZC)

    Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase

    Drug: Sodium Zirconium Cyclosilicate (SZC)

  • Active comparator
    Local standard of care (SoC)

    Participants discharged with SoC, as per local practice, to manage HK until the end of study.

    Drug: Local standard of care

Interventions

  • DrugSodium Zirconium Cyclosilicate (SZC)

    White to grey crystalline powder for oral suspension in 5 g sachets. Each sachet will be labeled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Label text will be translated into local language.

    Also known as: Lokelma

  • DrugLocal standard of care

    Local SoC in the country to be used as per local label

    Also known as: SoC

05

What researchers measure

Primary outcomes

  1. Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge

    A response was defined as a participant having serum K+ within 3.5 and 5.0 mmol/L at 180 days post-discharge. No response was defined as a participant who: 1) used rescue therapy for hyperkalaemia (HK) during the outpatient period; 1) died prior to 180 days post-discharge; 3) were missing an assessment at visit 10; 4) were lost to follow-up prior to 180 days post-discharge; 5) down-titrated (or discontinued) RAASi. The number of participants who had a response/no response is presented.

    Time frame: At 180 days post-discharge (Visit 10)

Secondary outcomes

  1. 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

    The time to first occurrence of all-cause hospital admission, emergency department (ED) visits with HK as a contributing factor, all-cause death or use of rescue therapy for HK was calculated as date of first occurrence of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.

    Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days

  2. 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

    The 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 was calculated as the earliest date of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up, date of 180 days post-discharge) - date of randomization + 1. The median time to event (days) is presented.

    Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days

  3. 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

    The 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 is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who down-titrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).

    Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days

  4. Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days

    The time to first occurrence of RAASi down-titration (or discontinuation) was calculated as date of first occurrence of (RAASi down-titration, all-cause death, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.

    Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days

  5. 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

    The time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor, was calculated as date of first occurrence of (Hospital admission or ED visit with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.

    Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days

  6. Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days

    The number of events (hospital admissions or ED visits) with HK as a contributing factor, at any time post-discharge up to 180 days is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who downtitrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).

    Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days

06

Results

Posted Nov 28, 2025
Limitations and caveats
Results should be interpreted with great caution due to a high and imbalanced missingness of K+ results from the central laboratory at Day 180 / Visit 10 (51.5% in the SZC group and 36.2% in the SoC group). Hence, results are only described with no conclusive statement.

Participant flow

A total of 186 participants were screened from 28 study sites across 6 countries.

Inpatient Period
Participant flow — Inpatient Period
MilestoneInpatient PeriodOutpatient Period - Arm A: SZCOutpatient Period - Arm B: Standard of Care (SoC)
Started18600
Completed13700
Not completed4900
Withdrew: Participant was discharged from the hospital but did not inform the site100
Withdrew: Withdrawal of consent1000
Withdrew: Failure to meet inclusion/exclusion criteria1900
Withdrew: Screening failure800
Withdrew: Death200
Withdrew: Physician decision500
Withdrew: Adverse event300
Withdrew: Withdrawn from study due to a mistaken request for study termination100
Outpatient Period
Participant flow — Outpatient Period
MilestoneInpatient PeriodOutpatient Period - Arm A: SZCOutpatient Period - Arm B: Standard of Care (SoC)
Started06869
Completed04256
Not completed02613
Withdrew: Adverse event090
Withdrew: Death062
Withdrew: Development of study-specific withdrawal criteria: severe hk001
Withdrew: Lost to follow-up001
Withdrew: Participant's study compliance was impossible to monitor and they had a complex private situation.010
Withdrew: Scheduled hemodialysis010
Withdrew: Severe hk001
Withdrew: Started dialysis on 16 feb 2023010
Withdrew: Start of dialysis001
Withdrew: The participant entered hemodialysis001
Withdrew: The participant moved to another city and could not attend the study visits001
Withdrew: Withdrawal by subject085

Outcome measures

PrimaryOccurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge

A response was defined as a participant having serum K+ within 3.5 and 5.0 mmol/L at 180 days post-discharge. No response was defined as a participant who: 1) used rescue therapy for hyperkalaemia (HK) during the outpatient period; 1) died prior to 180 days post-discharge; 3) were missing an assessment at visit 10; 4) were lost to follow-up prior to 180 days post-discharge; 5) down-titrated (or discontinued) RAASi. The number of participants who had a response/no response is presented.

Time frame:
At 180 days post-discharge (Visit 10)
Reported as:
Number · Number of participants
Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge
Number of participantsArm A: SZCArm B: SoC
Response2125
No response4744
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Regression, Logistic · p = 0.558 · Odds ratio (or): 0.81 · 95% CI 0.39 to 1.66OR \>1 indicated increased odds of K+ between 3.5 and 5.0 mmol/L on SZC compared to SoC.
SecondaryTime 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

The time to first occurrence of all-cause hospital admission, emergency department (ED) visits with HK as a contributing factor, all-cause death or use of rescue therapy for HK was calculated as date of first occurrence of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.

Time frame:
At any time post-discharge (from Visits 4 to 10), up to 180 days
Reported as:
Median · Days
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
DaysArm A: SZCArm B: SoC
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 Days136 (60.00 to NA)NA (63.00 to NA)
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Regression, Cox · p = 0.743 · Hazard ratio (hr): 0.92 · 95% CI 0.56 to 1.51An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.
SecondaryTime 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

The 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 was calculated as the earliest date of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up, date of 180 days post-discharge) - date of randomization + 1. The median time to event (days) is presented.

Time frame:
At any time post-discharge (from Visits 4 to 10), up to 180 days
Reported as:
Median · Days
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
DaysArm A: SZCArm B: SoC
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 DaysNA (116.00 to NA)NA (123.00 to NA)
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Regression, Cox · p = 0.951 · Hazard ratio (hr): 1.02 · 95% CI 0.58 to 1.79An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.
SecondaryNumber of All-cause Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days

The 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 is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who down-titrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).

Time frame:
At any time post-discharge (from Visits 4 to 10), up to 180 days
Reported as:
Mean · Events
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
EventsArm A: SZCArm B: SoC
Number of All-cause Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days0.7 ± 0.920.6 ± 0.83
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Negative binomial regression model · p = 0.152 · Incidence rate ratio: 1.48 · 95% CI 0.86 to 2.53A rate ratio \<1 favours SZC compared to SoC.
SecondaryTime to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days

The time to first occurrence of RAASi down-titration (or discontinuation) was calculated as date of first occurrence of (RAASi down-titration, all-cause death, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.

Time frame:
At any time post-discharge (from Visits 4 to 10), up to 180 days
Reported as:
Median · Days
Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days
DaysArm A: SZCArm B: SoC
Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 DaysNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Regression, Cox · p = 0.515 · Hazard ratio (hr): 1.42 · 95% CI 0.50 to 4.35An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.
SecondaryTime 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

The time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor, was calculated as date of first occurrence of (Hospital admission or ED visit with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.

Time frame:
At any time post-discharge (from Visits 4 to 10), up to 180 days
Reported as:
Median · Days
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
DaysArm A: SZCArm B: SoC
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 DaysNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Regression, Cox · p = 0.258 · Hazard ratio (hr): 0.41 · 95% CI 0.07 to 1.83An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.
SecondaryNumber of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days

The number of events (hospital admissions or ED visits) with HK as a contributing factor, at any time post-discharge up to 180 days is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who downtitrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).

Time frame:
At any time post-discharge (from Visits 4 to 10), up to 180 days
Reported as:
Mean · Events
Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days
EventsArm A: SZCArm B: SoC
Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days0.1 ± 0.240.1 ± 0.26
Statistical analysis
  • Arm A: SZC vs Arm B: SoC · Negative binomial regression model · p = 0.239 · Incidence risk ratio: 0.42 · 95% CI 0.10 to 1.81A rate ratio \<1 favours SZC compared to SoC.

Adverse events

Collected over Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Inpatient Period2/174 (1.1%)10/174 (5.7%)0/174 (0%)
Outpatient Period - Arm A: SZC6/68 (8.8%)29/68 (42.6%)22/68 (32.4%)
Outpatient Period - Arm B: SoC2/68 (2.9%)21/68 (30.9%)30/68 (44.1%)
Most frequent serious events
Showing 10 of 62
Most frequent serious events
EventInpatient PeriodOutpatient Period - Arm A: SZCOutpatient Period - Arm B: SoC
PneumoniaInfections and infestations0/1743/681/68
Acute kidney injuryRenal and urinary disorders0/1743/681/68
Urinary tract infectionInfections and infestations0/1742/681/68
HyperkalaemiaMetabolism and nutrition disorders0/1741/682/68
Chronic kidney diseaseRenal and urinary disorders0/1741/682/68
Cardiac failureCardiac disorders1/1742/682/68
Acute pulmonary oedemaRespiratory, thoracic and mediastinal disorders0/1742/680/68
DiarrhoeaGastrointestinal disorders0/1741/680/68
EnterocolitisGastrointestinal disorders0/1740/681/68
Gastric perforationGastrointestinal disorders0/1741/680/68
Most frequent other events
Most frequent other events
EventInpatient PeriodOutpatient Period - Arm A: SZCOutpatient Period - Arm B: SoC
HyperkalaemiaMetabolism and nutrition disorders0/17412/6817/68
AnaemiaBlood and lymphatic system disorders0/1743/688/68
Urinary tract infectionInfections and infestations0/1741/686/68
Renal impairmentRenal and urinary disorders0/1745/684/68
Metabolic acidosisMetabolism and nutrition disorders0/1743/684/68
Cardiac failureCardiac disorders0/1744/682/68

Baseline characteristics

Safety Set Randomized. Of the 137 participants randomised into the 2 arms (68 participants in Arm A: SZC and 69 participants in Arm B: SoC), there was one participant in Arm B: SoC who did not receive treatment during the outpatient period and was excluded from the safety analysis.

Age, Continuous
Age, Continuous(Years)Outpatient Period - Arm A: SZCOutpatient Period - Arm B: SoCTotal
Mean72.8 ± 10.2572.1 ± 10.9972.5 ± 10.59
Age, Customized
Age, Customized(Participants)Outpatient Period - Arm A: SZCOutpatient Period - Arm B: SoCTotal
18-64 years141327
65-84 years454792
>=85 years9817
Sex: Female, Male
Sex: Female, Male(Participants)Outpatient Period - Arm A: SZCOutpatient Period - Arm B: SoCTotal
Female251641
Male435295
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Outpatient Period - Arm A: SZCOutpatient Period - Arm B: SoCTotal
Hispanic or Latino211031
Not Hispanic or Latino435699
Not Reported426
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Outpatient Period - Arm A: SZCOutpatient Period - Arm B: SoCTotal
White6464128
Black or African American000
Asian011
Native Hawaiian or Other Pacific Islander000
American Indian or Alaskan Native000
Other000
Multiple000
Not Reported437
Country
Country(Participants)Outpatient Period - Arm A: SZCOutpatient Period - Arm B: SoCTotal
Belgium022
Spain5759116
France426
United Kingdom022
Italy639
Netherlands101
07

Study locations

28 sites
  • Research Site
    Bonheiden, 2820, Belgium
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Annonay, 07103, France
  • Research Site
    Ars-Laquenexy, 57530, France
  • Research Site
    Nice, 06000, France
  • Research Site
    Saint-Priest-en-Jarez, 42270, France
  • Research Site
    Bari, 70120, Italy
  • Research Site
    Foggia, 71122, Italy
  • Research Site
    Parma, 43125, Italy
  • Research Site
    Pavia, 27100, Italy
  • Research Site
    Eindhoven, 5602 ZA, Netherlands
  • Research Site
    Algeciras, 11207, Spain
  • Research Site
    Almería, 04009, Spain
  • Research Site
    Badajoz, 06080, Spain
  • Research Site
    Barcelona, 08907, Spain
  • Research Site
    Burgos, 9006, Spain
  • Research Site
    Getafe, 28905, Spain
  • Research Site
    Madrid, 28007, Spain
  • Research Site
    Madrid, 28040, Spain
  • Research Site
    Salamanca, 37007, Spain
  • Research Site
    San Sebastián de los Reyes, 28702, Spain
  • Research Site
    Seville, 41009, Spain
  • Research Site
    Talavera de la Reina, 45600, Spain
  • Research Site
    Zamora, 49022, Spain
  • Research Site
    Doncaster, DN2 5LT, United Kingdom
  • Research Site
    Hull, HU10 7AZ, United Kingdom
  • Research Site
    Salford, M6 8HD, United Kingdom
  • Research Site
    Stevenage, SG1 4AB, United Kingdom
08

References and documents

Publications

  • Burton JO, Allum AM, Amin A, Linde C, Lesen E, Mellstrom C, Eudicone JM, Sood MM. Rationale and design of CONTINUITY: a Phase 4 randomized controlled trial of continued post-discharge sodium zirconium cyclosilicate treatment versus standard of care for hyperkalemia in chronic kidney disease. Clin Kidney J. 2023 Mar 23;16(7):1160-1169. doi: 10.1093/ckj/sfad053. eCollection 2023 Jul. PubMed 37398685 ↗

Study documents

  • Study protocol · Nov 2, 2023
  • Statistical analysis plan · Jan 16, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT05347693
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Apr 26, 2022
Start date
Mar 24, 2022
Primary completion
Dec 10, 2024
Completion
Dec 10, 2024
Results posted
Nov 28, 2025
Last update
Nov 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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