Study identifier:D9480R00055
ClinicalTrials.gov identifier:NCT06185660
EudraCT identifier:N/A
CTIS identifier:N/A
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
N/A
No
sodium zirconium cyclosilicate (SZC)
All
125
Observational
18 Years - 100 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Chronic Kidney Disease patients not on dialysis Chronic Kidney Disease patients not on dialysis | 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. |
Chronic Disease Patients on dialysis Chronic Disease Patients on dialysis | 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. |
Heart Failure patients 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. |