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
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.
• Patient of 18 years of age or older at the time of index date (\*).
• Patient with a diagnosis of hyperkalaemia and/or serum potassium concentration ≥ 5 mmol/L recorded at or before the index date (\*).
• Patients with an estimated glomerular filtration rate (eGFR) less than 45 ml/min/1,73m2 recorded before the index date (\*).
• Patient who has initiated LokelmaTM from May 2021 until 3 months before the start data collection for each site (LokelmaTM must be used on label in accordance with Summary of Product Characteristic (SmPC)).
• Patient with a baseline measure of serum potassium levels at or within 7 days before the index date (\*).
• Patients with at least one follow-up visit during the study period.
• Patient with data recorded on electronic health records ≥ 6 month before index date (\*).
⁃ (\*) Index date: Day on which the patient starts treatment with SZC (LokelmaTM).