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Spanish hospitals track Real-World use of potassium drug

NCT ID NCT06635499

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how doctors in 20 Spanish hospitals use the drug Lokelma to treat patients with high potassium levels (hyperkalemia). Researchers collected information from 232 patients' medical records to understand how the drug is prescribed and how patients respond in real life. The goal was to learn about treatment patterns and outcomes, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

232 people

The number who actually took part.

Started

Nov 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hyperkalemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperkalaemia

Contacts and locations

Locations

  • Research Site

    A Coruña, Spain

  • Research Site

    Asturias, Spain

  • Research Site

    Badajoz, Spain

  • Research Site

    Barcelona, Spain

  • Research Site

    Burgos, Spain

  • Research Site

    Cadiz, Spain

  • Research Site

    Córdoba, Spain

  • Research Site

    Huelva, Spain

  • Research Site

    Lleida, Spain

  • Research Site

    Madrid, Spain

  • Research Site

    Málaga, Spain

  • Research Site

    Santa Cruz de Tenerife, Spain

  • Research Site

    Valencia, Spain

  • Research Site

    Zaragoza, Spain

More trials for these conditions

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