VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Se… (NCT06635499) | Clinical Trial Compass
CompletedNot Applicable
VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in Spain
Spain232 participantsStarted 2024-11-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation.
Timeframe: From May 2021 up to 3 months before the start of data collection
2
To describe the usual HK management after treatment initiation with SZC in the real-world setting.
Timeframe: From May 2021 up to 3 months before the start of data collection
. Patient with data recorded on electronic health records ≥ 6 month before index date (\*).
Exclusion criteria
. Patient presenting pseudohyperkalaemia
. Patients receiving renal replacement therapy
. Patient who is pregnant or breastfeeding.
. 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).
. Patient who has explicitly refused consent to participate in research.
. Patient medical chart is not available for data extraction or the information in it is not analyzable.