Tracking Treatment Pathways in Adult Patients With Hyperkalemia.
TRACK
A Prospective, Non-interventional, Longitudinal Study of the Treatment Journey of Adult Patients With Hyperkalemia
1 other identifier
observational
1,331
5 countries
74
Brief 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. 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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Typical duration for all trials
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedStudy Start
First participant enrolled
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2024
CompletedJuly 15, 2025
July 1, 2025
2.4 years
May 18, 2022
July 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Description of change in HK management decision at 3 month intervals.
Up to 12 months following enrolment.
Description of HK management objective(s) decision at 3 month intervals.
Up to 12 months following enrolment.
Description of expected HK management duration decision at 3 month intervals.
Up to 12 months following enrolment.
Secondary Outcomes (6)
Change in time to K+ normalization at 3 month intervals.
Up to 12 months following enrolment.
Description of HK recurrence frequency.
Up to 12 months following enrolment.
Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy.
Up to 12 months following enrolment.
Change in time to achieve target dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy at 3 month intervals.
Up to 12 months following enrolment.
Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis.
Up to 12 months following enrolment.
- +1 more secondary outcomes
Other Outcomes (1)
Description of change in awareness and satisfaction to HK management by patient reported outcome (PRO) at 3 month intervals.
Up to 12 months following enrolment.
Eligibility Criteria
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.
You may qualify if:
- Age ≥18 years on the date of signing informed consent
- 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\*
- 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:
- Concurrent participation in any trial that includes the use of K+ binders as an investigational medicinal product (IMP)
- Patients with pseudohyperkalemia
- A life expectancy of less than six months, based on physician judgement
- Acute causes of HK such as infections and/or trauma to be determined by the principal investigator
- Scheduled renal transplant
- Involvement in the planning and/or conduct of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (74)
Research Site
Huntsville, Alabama, 35805, United States
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La Jolla, California, 92037, United States
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Rancho Cucamonga, California, 91730, United States
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New Haven, Connecticut, 06511, United States
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Nampa, Idaho, 83687, United States
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Hinsdale, Illinois, 60521, United States
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Princeton, New Jersey, 08540, United States
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Albany, New York, 12208, United States
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New York, New York, 10011, United States
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Abington, Pennsylvania, 19001, United States
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Doylestown, Pennsylvania, 18901, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Providence, Rhode Island, 02903, United States
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Edinburg, Texas, 78539, United States
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Houston, Texas, 77089, United States
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Burlington, Vermont, 05401, United States
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Bad Krozingen, Germany
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Berlin, Germany
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Coburg, Germany
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Dresden, Germany
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Fulda, Germany
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Göttingen, Germany
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Halle, Germany
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Papenburg, Germany
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Stuttgart, Germany
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Bari, Italy
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Bologna, Italy
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Brescia, Italy
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Catanzaro, Italy
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Florence, Italy
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Genova, Italy
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Lecco, Italy
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Milan, Italy
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Napoli, Italy
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Padua, Italy
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Parma, Italy
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Pisa, Italy
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Rome, Italy
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Rozzano, Italy
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San Giovanni Rotondo, Italy
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Sassari, Italy
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Trieste, Italy
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Badalona, Spain
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Barcelona, Spain
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El Ejido, Spain
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El Palmar, Spain
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Ferrol, Spain
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Gij N, Spain
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Girona, Spain
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Granada, Spain
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Ja N, Spain
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Madrid, Spain
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Majadahonda, Spain
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Salamanca, Spain
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San Sebasti N de Los Reyes, Spain
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Sant Joan Despí, Spain
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Zaragoza, Spain
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Ashford, United Kingdom
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Barnet, United Kingdom
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Barnstaple, United Kingdom
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Birkenhead, United Kingdom
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Bradford, United Kingdom
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Bristol, United Kingdom
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Calow, United Kingdom
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Dorchester, United Kingdom
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Headington, United Kingdom
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High Heaton/Newcastle Upon Tyn, United Kingdom
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Hull, United Kingdom
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Kogarah, United Kingdom
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London, United Kingdom
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Preston, United Kingdom
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Salford, United Kingdom
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Stevenage, United Kingdom
Related Publications (1)
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.
PMID: 39464260DERIVED
Related Links
Biospecimen
Not applicable. No Samples Retained
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2022
First Posted
June 7, 2022
Study Start
July 14, 2022
Primary Completion
December 19, 2024
Study Completion
December 19, 2024
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.