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

Hyperkalaemia Clinical Trial

— SHIELD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185660
• Other study ID #: D9480R00055
• Status: Recruiting
• Start date: February 9, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalaemia
• Hyperkalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Greece	Research Site	Alexandroupolis
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Heraklion
Greece	Research Site	Larissa
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Enrollment time point, 3 months after enrollment, 6 months after enrollment