An observational study in Hyperkalaemia, sponsored by AstraZeneca. Completed at 10 sites in Greece. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by AstraZeneca · Observational
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.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 125 is below the median of 459 across 30 observational studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
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Approximately 120 hyperkalaemia patients with serum potassium level >5.0 mmol/L, being treated with sodium zirconium cyclosilicate (SZC) for hyperkalaemia at the time of enrolment as per Summary of Product Characteristics (SmPC), assigned in a 2:1:1 ratio to one of the following 3 groups: (1) chronic kidney disease (CKD) patients not on dialysis (60 patients), (2) chronic kidney disease (CKD) patients on dialysis (30 patients) and (3) heart failure (HF) patients receiving Renin angiotensin aldosterone inhibitors/Mineralocorticoid receptor antagonists (RAASi/MRAs) therapy (30 patients)
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic Kidney Disease patients not on dialysis
Drug: sodium zirconium cyclosilicate (SZC)
Chronic Disease Patients on dialysis
Drug: sodium zirconium cyclosilicate (SZC)
Heart Failure patients receiving Renin angiotensin aldosterone inhibitors/Mineralocorticoid receptor antagonists (Raas i/Mras)
Drug: 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.
To record the treatment patterns and characteristics of patients with hyperkalaemia receiving Sodium Zirconium Cyclosilicate (SZC)
To describe the treatment patterns and patient characteristics of hyperkalaemia patients receiving Sodium Zirconium Cyclosilicate (SZC), by recording any pharmacological and other intervention administered, including dose and frequency of administration
Time frame: Enrollment time point, 3 months after enrollment, 6 months after enrollment
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 Vivli.org. All requests 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 approved.
Supporting information: Clinical study report
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
Ran from Feb 2024 to primary completion in Jan 2025, 10 months.
Of 20 observational studies under Hyperkalemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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