Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Hyperkalaemia

Eligibility:

All Genders

18-100 years

Brief 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 zirco...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 9 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 3 2025

Estimated Enrollment :

125 Patients enrolled

Trial Details

Trial ID

NCT06185660

Start Date

February 9 2024

End Date

January 3 2025

Last Update

December 30 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Research Site

Alexandroupoli, Greece, 68100

2

Research Site

Athens, Greece, 10676

3

Research Site

Athens, Greece, 11527

4

Research Site

Athens, Greece, 12462