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A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece

NCT ID: NCT06185660

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-09

Study Completion Date

2025-01-03

Brief Summary

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This is a multicenter, observational, prospective, national study which includes patients with chronic kidney disease (CKD) under dialysis or not, or with heart failure (HF), treated with sodium zirconium cyclosilicate (SZC) as per Summary of Product Characteristics (SmPC), aiming to collect information on patient characteristics, routine clinical practice and treatments administered for managing hyperkalaemia in a real-world setting in Greece. It will include approximately 12 public hospital and clinic based nephrology, or cardiology sites throughout the country. Sites and investigators will be selected so to represent the management of patients with CKD under dialysis or not, or with HF receiving Renin angiotensin aldosterone inhibitors/Mineralocorticoid receptor antagonists (RAASi/MRAs) therapy, and treated with sodium zirconium cyclosilicate (SZC) as per SmPC at a national level. The final selection of the participating sites will be based on a documented feasibility evaluation process that will assess physicians' qualifications, previous participation, and experience in similar clinical studies. Data will be obtained prospectively during the study visits as performed per standard clinical practice. Data regarding the patient's medical history will be collected retrospectively from patient medical charts records. Physicians will monitor eligible patients and will record their management according to their usual clinical practice. Only medical records available from the clinical practice and provided by the physicians will be used in this study as source documentation and the data will be entered into the electronic Case Report Form. Therefore, the collected data will reflect usual clinical practice. The study will enroll approximately 120 hyperkalaemia patients with serum potassium level \>5.0 mmol/L, being treated with sodium zirconium cyclosilicate for hyperkalaemia at the time of enrolment as per SmPC, assigned in a 2:1:1 ratio to one of the following 3 groups: (1) CKD patients not on dialysis (60 patients), (2) CKD patients on dialysis (30 patients) and (3) HF patients receiving RAASi/MRAs therapy (30 patients), all consisting the study population. Patients will be followed for 6 months, with a 6-month recruitment period, for a total study duration of 12 months.

Detailed Description

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Conditions

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Hyperkalaemia

Keywords

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Hyperkalaemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Kidney Disease patients not on dialysis

Chronic Kidney Disease patients not on dialysis

sodium zirconium cyclosilicate (SZC)

Intervention Type DRUG

sodium zirconium cyclosilicate (SZC), 5g or 10g of white to grey powder in a foil-lined packet. Starting dose of SZC is 10g, administered three times a day orally as a suspension in water. When normokalaemia has been achieved, starting dose of 5g once daily is recommended, with possible titration up to 10g once daily, or down to 5g once every other day, as needed, to maintain a normal potassium level. No more than 10g once daily should be used for maintenance therapy.

Chronic Disease Patients on dialysis

Chronic Disease Patients on dialysis

sodium zirconium cyclosilicate (SZC)

Intervention Type DRUG

sodium zirconium cyclosilicate (SZC), 5g or 10g of white to grey powder in a foil-lined packet. Starting dose of SZC is 10g, administered three times a day orally as a suspension in water. When normokalaemia has been achieved, starting dose of 5g once daily is recommended, with possible titration up to 10g once daily, or down to 5g once every other day, as needed, to maintain a normal potassium level. No more than 10g once daily should be used for maintenance therapy.

Heart Failure patients

Heart Failure patients receiving Renin angiotensin aldosterone inhibitors/Mineralocorticoid receptor antagonists (Raas i/Mras)

sodium zirconium cyclosilicate (SZC)

Intervention Type DRUG

sodium zirconium cyclosilicate (SZC), 5g or 10g of white to grey powder in a foil-lined packet. Starting dose of SZC is 10g, administered three times a day orally as a suspension in water. When normokalaemia has been achieved, starting dose of 5g once daily is recommended, with possible titration up to 10g once daily, or down to 5g once every other day, as needed, to maintain a normal potassium level. No more than 10g once daily should be used for maintenance therapy.

Interventions

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sodium zirconium cyclosilicate (SZC)

sodium zirconium cyclosilicate (SZC), 5g or 10g of white to grey powder in a foil-lined packet. Starting dose of SZC is 10g, administered three times a day orally as a suspension in water. When normokalaemia has been achieved, starting dose of 5g once daily is recommended, with possible titration up to 10g once daily, or down to 5g once every other day, as needed, to maintain a normal potassium level. No more than 10g once daily should be used for maintenance therapy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent Form.
* Older than 18 years at the time of consent.
* Treated with sodium zirconium cyclosilicate (SZC) for hyperkalaemia at the time of enrolment, and having started receiving sodium zirconium cyclosilicate (SZC) at least 10 days before enrolment.
* Patients diagnosed with hyperkalaemia (Serum Potassium (S-K)+ \>5.0 mmol/L), and with chronic kidney disease (CKD) not on dialysis (Group 1) or on dialysis (Group 2), or with heart failure (HF), receiving Renin angiotensin aldosterone inhibitors/Mineralocorticoid receptor antagonists (RAASi/MRAs) therapy (Group 3).

Exclusion Criteria

* Patients who are pregnant, breast-feeding, or planning to become pregnant.
* Patients already participating in another clinical trial.
* Presence of a condition that, in the opinion of the investigator: i) would put the subject at undue risk, or ii) would potentially jeopardize the quality of the data to be generated, or iii) would, for some other reason, make the patient inappropriate for this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Alexandroupoli, , Greece

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Heraklion, , Greece

Site Status

Research Site

Larissa, , Greece

Site Status

Research Site

Pátrai, , Greece

Site Status

Research Site

Thessaloniki, , Greece

Site Status

Research Site

Thessaloniki, , Greece

Site Status

Countries

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Greece

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9480R00055&attachmentIdentifier=483d5244-08f6-4c46-8a5b-342b815b6942&fileName=D9480R00055_SHIELD_Clinical_Study_Report_Synopsis_final_22Dec2025_Redacted.pdf&versionIdentifier=

D9480R00055\_CSR Synopsis\_Redacted

Other Identifiers

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D9480R00055

Identifier Type: -

Identifier Source: org_study_id