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 — SHIELD

Hyperkalaemia Clinical Trial

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

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06185660
Study type	Observational
Source	AstraZeneca
Contact	AstraZeneca Clinical Study Information Center
Phone	1-877-240-9479
Email	information.center@astrazeneca.com
Status	Recruiting
Phase
Start date	February 9, 2024
Completion date	March 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04676646` - Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone	Phase 4
Completed	`NCT04788641` - Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects	Phase 1
Recruiting	`NCT05347693` - Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study	Phase 4
Active, not recruiting	`NCT05271266` - A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
Terminated	`NCT04727528` - Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease	Phase 3
Recruiting	`NCT04249648` - Hyperkalaemia and Its Impact on Therapy With RAASi
Completed	`NCT05462119` - Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
Terminated	`NCT04997161` - Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia	Phase 4
Recruiting	`NCT03813407` - An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.