Clinical Research Directory

VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in Spain

Sponsor: AstraZeneca

Summary

Primary Objective(s) \& Hypothesis(es) 1. To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation. 2. To describe the usual HK management after treatment initiation with SZC in the real-world setting. Secondary Objective(s) \& Hypothesis(es) 1. To describe treatment patterns of patients treated with SZC in the real-world setting, as well as the SZC treatment duration. 2. To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting. 3. To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting. 4. To describe Healthcare Resource Utilization (HCRU) before and after SZC initiation in patients treated with SZC in the real-world setting. 5. To analyse specific characteristics of use of SZC in the real-world setting according to the medical specialties. For that purpose, a non-interventional, multicenter, longitudinal study, with secondary data collection has been designed involving 20 Spanish public hospitals ans aiming to include 230 patients (10-12 patients per site) has been designed.

Official title: A Non-interVentional, multI-center and longiTudinAL Study to Describe the Use of SodIum Zirconium CyclosilicatE (LokelmaTM) in Patients Diagnosed With Hyperkalemia in the Real-world Setting in Spain: VITALIZE Study

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