Continuing Sodium Zirconium Cyclosilicate (SZC) after discharge study

An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) after Discharge in Participants with Chronic Kidney Disease treated for Hyperkalaemia - CONTINUITY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003527-14-ES

Enrollment

344

Registered

2021-10-19

Start date

2021-11-15

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Chronic Kidney Disease treated for Hyperkalaemia whilst in hospital, who are normokalemic and established on maintenance dose of SZC at discharge. MedDRA version: 21.1 Level: PT Classification code 10020646 Term: Hyperkalaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Lokelma Product Name: Sodium zirconium cyclosilicate Product Code: SZC Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: Sodium zirconium cyclosilicate CAS Number: 24280

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 224

Exclusion criteria

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 (see Appendix C) 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 postmenopausal) 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: (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 (IUD) (d) Intrauterine hormone-releasing system (IUS) (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 t

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK;Secondary Objective: To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC: 1. in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue-therapy for HK 2. in reducing the incidence of the composite outcome of hospital admissions with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 3. in reducing the incidence of ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 4. in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor or all-cause death 5. in reducing the incidence of hospital admissions with HK as a contributing factor or all-cause death 6. in reducing the incidence of ED visits with HK as a contributing factor or all-cause death;Primary end point(s): Occurrence (yes/no) of NK (K+ between 3.5 and 5.0 mmol/L, inclusive) at 180 days post-discharge.;Timepoint(s) of evaluation of this end point: Up to 180 days post-discharge	—

Measure

Time frame

Main Objective: To evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK;Secondary Objective: To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC: 1. in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue-therapy for HK 2. in reducing the incidence of the composite outcome of hospital admissions with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 3. in reducing the incidence of ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 4. in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor or all-cause death 5. in reducing the incidence of hospital admissions with HK as a contributing factor or all-cause death 6. in reducing the incidence of ED visits with HK as a contributing factor or all-cause death;Primary end point(s): Occurrence (yes/no) of NK (K+ between 3.5 and 5.0 mmol/L, inclusive) at 180 days post-discharge.;Timepoint(s) of evaluation of this end point: Up to 180 days post-discharge

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Secondary

Measure	Time frame
Secondary end point(s): Time to first occurrence of: 1. hospital admissions or ED visits with HK as a contributing factor, use of rescue therapy for HK, or all-cause death (composite outcome) 2. hospital admission with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 3. ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 4, 5 and 6: either component of the composite outcome in point 1;Timepoint(s) of evaluation of this end point: At any time post-discharge up to 180 days.	—

Measure

Time frame

Secondary end point(s): Time to first occurrence of: 1. hospital admissions or ED visits with HK as a contributing factor, use of rescue therapy for HK, or all-cause death (composite outcome) 2. hospital admission with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 3. ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK 4, 5 and 6: either component of the composite outcome in point 1;Timepoint(s) of evaluation of this end point: At any time post-discharge up to 180 days.

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Countries

Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

Contacts

Public ContactClinical Study Information Center

AstraZeneca AB

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 9, 2026