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

NCT06635499 | Completed

• 1 other identifier: D9480R00047
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 14

Brief Summary

Primary Objective(s) \& Hypothesis(es)

1. 1.To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation.
2. 2.To describe the usual HK management after treatment initiation with SZC in the real-world setting.
3. 3.To describe treatment patterns of patients treated with SZC in the real-world setting, as well as the SZC treatment duration.
4. 4.To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting.
5. 5.To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting.
6. 6.To describe Healthcare Resource Utilization (HCRU) before and after SZC initiation in patients treated with SZC in the real-world setting.
7. 7.To analyse specific characteristics of use of SZC in the real-world setting according to the medical specialties.

Conditions

Hyperkalaemia

Outcome Measures

Primary Outcomes (2)

• To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation.

  From May 2021 up to 3 months before the start of data collection

• To describe the usual HK management after treatment initiation with SZC in the real-world setting.

  From May 2021 up to 3 months before the start of data collection

Secondary Outcomes (5)

• To describe treatment patterns of patients treated with SZC in the real-world setting, as well as the SZC treatment duration.

  From May 2021 up to 3 months before the start of data collection

• To describe baseline sociodemographic and clinical characteristics of patients treated with SZC in the real-world setting.

  From May 2021 up to 3 months before the start of data collection

• To describe the evolution of kalaemia and other clinical parameters as well as mortality in patients treated with SZC in the real-world setting.

  From May 2021 up to 3 months before the start of data collection

• To describe Healthcare Resource Utilization (HCRU) before and after SZC initiation in patients treated with SZC in the real-world setting.

  From May 2021 up to 3 months before the start of data collection

• To analyze specific characteristics of use of SZC according to the medical specialties

  From May 2021 up to 3 months before the start of data collection

Other Outcomes (2)

• Exploratory Objective: To describe the characteristics of the SZC responder patient according to potassium levels at first visit.

  From May 2021 up to 3 months before the start of data collection

• Safety Objective: To describe adverse events in patients treated with SZC in the real-world setting.

  From May 2021 up to 3 months before the start of data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study targets enrolment of approximately 230 patients diagnosed with hyperkalaemia who have been treated with LokelmaTM following SmPC from May 2021 up to 3 months before the start of data collection per each site in Spain. It is expected to include 20 Spanish public hospitals. Initially, each site will aim to include 10-12 patients; however, the study may turn into competitive if needed to meet the planned timelines.

You may qualify if:

• 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).

You may not qualify if:

• Patient presenting pseudohyperkalaemia
• Patients receiving renal replacement therapy
• Patient who is pregnant or breastfeeding.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

A Coruña, Spain

Location

Research Site

Asturias, Spain

Location

Research Site

Badajoz, Spain

Location

Research Site

Barcelona, Spain

Location

Research Site

Burgos, Spain

Location

Research Site

Cadiz, Spain

Location

Research Site

Córdoba, Spain

Location

Research Site

Huelva, Spain

Location

Research Site

Lleida, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Santa Cruz de Tenerife, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Zaragoza, Spain

Location

Related Publications (5)

• De Sequera Ortíz P, A. A. (2021). Trastornos del Potasio. Hipopotasemia. En Nefrología al día. S.l (págs. 2659-2606). Lorenzo V., López Gómez JM (Eds).

  RESULT

• Rose BD, P. T. (2001). Hypokalemia. Clinical physiology of acid-base and electrolyte disorders. New York: McGraw-Hill.

  RESULT

• Humphrey T, Davids MR, Chothia MY, Pecoits-Filho R, Pollock C, James G. How common is hyperkalaemia? A systematic review and meta-analysis of the prevalence and incidence of hyperkalaemia reported in observational studies. Clin Kidney J. 2021 Dec 2;15(4):727-737. doi: 10.1093/ckj/sfab243. eCollection 2022 Apr.

  PMID: 35371465 RESULT

• Larivee NL, Michaud JB, More KM, Wilson JA, Tennankore KK. Hyperkalemia: Prevalence, Predictors and Emerging Treatments. Cardiol Ther. 2023 Mar;12(1):35-63. doi: 10.1007/s40119-022-00289-z. Epub 2022 Dec 12.

  PMID: 36503972 RESULT

• Palmer BF, L. M. (1996). Effect of aging on renal function and disease. The Kidney. Philadelphia: Brenner & Rector's.

  RESULT

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 10, 2024
• Study Start: November 13, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (14)