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

NCT06635499 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Hyperkalaemia

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-05-20
Completion
2025-05-20

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635499 on ClinicalTrials.gov