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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Hyperkalaemia

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Patient of 18 years of age or older at the time of index date (\*).
2. Patient with a diagnosis of hyperkalaemia and/or serum potassium concentration ≥ 5 mmol/L recorded at or before the index date (\*).
3. Patients with an estimated glomerular filtration rate (eGFR) less than 45 ml/min/1,73m2 recorded before the index date (\*).
4. 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)).
5. Patient with a baseline measure of serum potassium levels at or within 7 days before the index date (\*).
6. Patients with at least one follow-up visit during the study period.
7. 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).

Exclusion Criteria:

1. Patient presenting pseudohyperkalaemia
2. Patients receiving renal replacement therapy
3. Patient who is pregnant or breastfeeding.
4. Patient who, at the time of inclusion in the study, is participating in a clinical trial that includes the use of K+ binders as an investigational medicinal product (IMP).
5. Patient who has explicitly refused consent to participate in research.
6. Patient medical chart is not available for data extraction or the information in it is not analyzable.

Locations (14)

A Coruña, Spain
Asturias, Spain
Badajoz, Spain
Barcelona, Spain
Burgos, Spain
Cadiz, Spain
Córdoba, Spain
Huelva, Spain
Lleida, Spain
Madrid, Spain
Málaga, Spain
Santa Cruz de Tenerife, Spain
Valencia, Spain
Zaragoza, Spain