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HyperkalemiaTRACKNCT05408039

Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

An observational study of Hyperkalemia, run by AstraZeneca at 74 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Hyperkalemia
How many people
1,331 participants
Where
74 sitesin 5 countries
Study dates
14 Jul 2022to 19 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with established HK (K+ levels >5.0 mmol/L) at selected sites distributed across USA and Europe will be recruited by the principal investigators to participate in the study. This is a non-interventional study. As such, patients will undergo clinical assessments and receive standard medical care as determined by their treating physicians. Patients will not receive any experimental disease management intervention or experimental treatment because of their participation in the study.

Patients meeting all the following inclusion criteria will be eligible for inclusion into the study:

  1. Age ≥18 years on the date of signing informed consent
  2. HK with serum potassium (K+) level(s) greater than 5.0 mmol/L, collected during Standard of Care, within 21 days prior to the date of enrollment*
  3. Provision of signed and dated informed consent (*enrollment in study is defined as the date of Informed consent and confirmation of study eligibility, whichever occurs later).

Patients will be excluded from the study if they meet any of the following criteria:

  1. Concurrent participation in any trial that includes the use of K+ binders as an investigational medicinal product (IMP)
  2. Patients with pseudohyperkalemia
  3. A life expectancy of less than six months, based on physician judgement
  4. Acute causes of HK such as infections and/or trauma to be determined by the principal investigator
  5. Scheduled renal transplant
  6. Involvement in the planning and/or conduct of the study

Trial locations and contacts

74 sites in 5 countries.

74 sites in 5 countries

United States17 sites

  • Research Site

    Abington, Pennsylvania, 19001

  • Research Site

    Albany, New York, 12208

  • Research Site

    Burlington, Vermont, 05401

  • Research Site

    Doylestown, Pennsylvania, 18901

  • Research Site

    Edinburg, Texas, 78539

  • Research Site

    Hinsdale, Illinois, 60521

  • Research Site

    Houston, Texas, 77089

  • Research Site

    Huntsville, Alabama, 35805

  • Research Site

    La Jolla, California, 92037

  • Research Site

    Nampa, Idaho, 83687

  • Research Site

    New Haven, Connecticut, 06511

  • Research Site

    New York, New York, 10011

  • Research Site

    Philadelphia, Pennsylvania, 19140

  • Research Site

    Pittsburgh, Pennsylvania, 15206

  • Research Site

    Princeton, New Jersey, 08540

  • Research Site

    Providence, Rhode Island, 02903

  • Research Site

    Rancho Cucamonga, California, 91730

Other trials in United States

Italy17 sites

  • Research Site

    Bari

  • Research Site

    Bologna

  • Research Site

    Brescia

  • Research Site

    Catanzaro

  • Research Site

    Florence

  • Research Site

    Genova

  • Research Site

    Lecco

  • Research Site

    Milan

  • Research Site

    Naples

  • Research Site

    Padova

  • Research Site

    Parma

  • Research Site

    Pisa

  • Research Site

    Rome

  • Research Site

    Rozzano

  • Research Site

    San Giovanni Rotondo

  • Research Site

    Sassari

  • Research Site

    Trieste

Other trials in Italy

United Kingdom16 sites

  • Research Site

    Ashford

  • Research Site

    Barnet

  • Research Site

    Barnstaple

  • Research Site

    Birkenhead

  • Research Site

    Bradford

  • Research Site

    Bristol

  • Research Site

    Calow

  • Research Site

    Dorchester

  • Research Site

    Headington

  • Research Site

    High Heaton/Newcastle Upon Tyn

  • Research Site

    Hull

  • Research Site

    Kogarah

  • Research Site

    London

  • Research Site

    Preston

  • Research Site

    Salford

  • Research Site

    Stevenage

Other trials in United Kingdom

Spain15 sites

  • Research Site

    Badalona

  • Research Site

    Barcelona

  • Research Site

    El Ejido

  • Research Site

    El Palmar

  • Research Site

    Ferrol

  • Research Site

    Gij N

  • Research Site

    Girona

  • Research Site

    Granada

  • Research Site

    Ja N

  • Research Site

    Madrid

  • Research Site

    Majadahonda

  • Research Site

    Salamanca

  • Research Site

    San Sebasti N de Los Reyes

  • Research Site

    Sant Joan Despí

  • Research Site

    Zaragoza

Other trials in Spain

Germany9 sites

  • Research Site

    Bad Krozingen

  • Research Site

    Berlin

  • Research Site

    Coburg

  • Research Site

    Dresden

  • Research Site

    Fulda

  • Research Site

    Göttingen

  • Research Site

    Halle

  • Research Site

    Papenburg

  • Research Site

    Stuttgart

Other trials in Germany

About this study

Official title: A Prospective, Non-interventional, Longitudinal Study of the Treatment Journey of Adult Patients With Hyperkalemia

This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. The generation of real-world evidence (RWE) to understand the treatment management decision rationale and to prospectively describe patient characteristics, treatment management patterns among patients with HK is of importance to improve adherence to guidelines and improve patient care.

The primary objective:

Read more
  • Describe HK management decisions, their rationale and treatment expectations.

The secondary objective:

  • Describe baseline characteristics and longitudinal clinical variables in patients with HK.

The exploratory objective:

  • Describe patient awareness and satisfaction with their HK treatment management across the study period.
Read the detailed description

This study is a multinational, observational, prospective, longitudinal, cohort study that will include primary and secondary data collection. Secondary data, collected as per routine clinical practice will be extracted from electronic health records (EHR) and manually entered into the electronic case report form (eCRF). Primary data will be collected directly from patients and Health Care Providers (HCPs). Prospective data collection will be performed for a period of 12 months and will include data collection at baseline, that is, the date of enrollment, and at 3-, 6-, 9-, and 12-months following baseline. The data collection timepoints in this study is irrespective of when the patient's medical visits are scheduled. There are no study specific patient visits mandated by protocol and study may be fully virtual.

Conditions
Hyperkalemia
Keywords
Treatment pathways,, Hyperkalemia,, High level of Serum potassium., Treatment rationale,, Treatment objective,, Treatment expectations,, Heart failure and, Chronic kidney disease.
Medical subject headings
Hyperkalemia, Heart Failure, Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Description of change in HK management decision at 3 month intervals.

    Measured: Up to 12 months following enrolment.

  2. Description of HK management objective(s) decision at 3 month intervals.

    Measured: Up to 12 months following enrolment.

  3. Description of expected HK management duration decision at 3 month intervals.

    Measured: Up to 12 months following enrolment.

Secondary outcomes (6)

  1. Change in time to K+ normalization at 3 month intervals.

    Measured: Up to 12 months following enrolment.

  2. Description of HK recurrence frequency.

    Measured: Up to 12 months following enrolment.

  3. Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy.

    Measured: Up to 12 months following enrolment.

  4. Change in time to achieve target dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy at 3 month intervals.

    Measured: Up to 12 months following enrolment.

  5. Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis.

    Measured: Up to 12 months following enrolment.

  6. Description of Healthcare resource utilization (HCRU).

    Measured: Up to 12 months following enrolment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start14 Jul 2022
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05408039
Sponsor's protocol ID
D9480R00048
Acronym
TRACK
Status last verified
Jul 2025
First submitted
18 May 2022
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

  • Gosmanova EO, Butler J, Contreras JP, Fried LF, Kathresal A, Winkelmayer WC, Chen H, Desai P, Sanford M, Wittbrodt E, Hsia J. Hyperkalemia Management in the US Cohort of the Prospective, Observational, Real-World TRACK Study. Adv Ther. 2026 Aug 21. doi: 10.1007/s12325-026-03738-6. Online ahead of print.

    PubMed 42627452

  • Hsia J, Shivappa N, Bakhai A, Bover J, Butler J, Ferraro PM, Fried L, Schneider MP, Tangri N, Winkelmayer WC, Bishop M, Chen H, Sundin AK, Bonaca MP. Design and cohort characteristics of TRACK, a prospective study of hyperkalaemia management decision-making. Clin Kidney J. 2024 Sep 30;17(10):sfae295. doi: 10.1093/ckj/sfae295. eCollection 2024 Oct.

    PubMed 39464260

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperkalemia, run by AstraZeneca at 74 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Italy, United Kingdom, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of change in HK management decision at 3 month intervals. (time frame: Up to 12 months following enrolment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408039, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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