Tracking Treatment Pathways in Adult Patients With Hyperkalemia. (TRACK)

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:

• 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperkalemia

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.

• Study Type: Observational
• Enrollment (Actual): 1297

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Research Site
  • Berlin, Germany, 12200
    • Research Site
  • Berlin, Germany, 13353
    • Research Site
  • Berlin, Germany, 10789
    • Research Site
  • Berlin, Germany, 10365
    • Research Site
  • Berlin, Germany, 10559
    • Research Site
  • Baden Wuerttemberg
    • Bad Krozingen, Baden Wuerttemberg, Germany, 79189
      • Research Site
    • Heilbronn, Baden Wuerttemberg, Germany, 74076
      • Research Site
    • Stuttgart, Baden Wuerttemberg, Germany, 70376
      • Research Site
  • Hessen
    • Fulda, Hessen, Germany, 36037
      • Research Site
  • Niedersachsen
    • Goettingen, Niedersachsen, Germany, 37075
      • Research Site
    • Papenburg, Niedersachsen, Germany, 26871
      • Research Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • Research Site
  • Sachsen Anhalt
    • Halle, Sachsen Anhalt, Germany, 06120
      • Research Site
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • Research Site
    • Luebeck, Schleswig Holstein, Germany, 23538
      • Research Site
  • Thueringen
    • Erfurt, Thueringen, Germany, 99089
      • Research Site
• Italy
  • Avellino, Italy, 83100
    • Research Site
  • Bari, Italy, 70124
    • Research Site
  • Bologna, Italy, 40138
    • Research Site
  • Brescia, Italy, 25123
    • Research Site
  • Catanzaro, Italy, 88100
    • Research Site
  • Chieti, Italy, 66013
    • Research Site
  • Firenze, Italy, 50134
    • Research Site
  • Firenze, Italy, 50143
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Lecco, Italy, 23900
    • Research Site
  • Messina, Italy, 98124
    • Research Site
  • Milano, Italy, 20157
    • Research Site
  • Milano, Italy, 20158
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Napoli, Italy, 80138
    • Research Site
  • Parma, Italy, 43100
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Pisa, Italy, 56126
    • Research Site
  • Roma, Italy, 00137
    • Research Site
  • Trieste, Italy, 34100
    • Research Site
  • Verona, Italy, 37126
    • Research Site
  • Ancona
    • Torrette Di Ancona, Ancona, Italy, 60126
      • Research Site
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Research Site
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Research Site
  • Padova
    • Padova PD, Padova, Italy, 35122
      • Research Site
• Spain
  • Barcelona, Spain, 08907
    • Research Site
  • Girona, Spain, 17007
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Jaen, Spain, 23007
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Salamanca, Spain, 37007
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
  • Almeria
    • El Ejido, Almeria, Spain, 4700
      • Research Site
  • Asturias
    • Gijon, Asturias, Spain, 33206
      • Research Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Research Site
    • Sant Joan Despi, Barcelona, Spain, 08970
      • Research Site
  • La Coruna
    • Ferrol, La Coruna, Spain, 15405
      • Research Site
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Research Site
    • San Sebastian de los Reyes, Madrid, Spain, 28702
      • Research Site
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Research Site
• United Kingdom
  • Avon
    • Bristol, Avon, United Kingdom, BS10 5NB
      • Research Site
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S44 5BL
      • Research Site
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8BQ
      • Research Site
  • Dorset
    • Dorchester, Dorset, United Kingdom, DT1 2JY
      • Research Site
  • East Riding Of Yorkshire
    • Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
      • Research Site
  • Greater London
    • London, Greater London, United Kingdom, SW17 0QT
      • Research Site
    • London, Greater London, United Kingdom, E1 1FR
      • Research Site
    • London, Greater London, United Kingdom, SE1 9RT
      • Research Site
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Research Site
  • Hertfordshire
    • Barnet, Hertfordshire, United Kingdom, EN5 3DJ
      • Research Site
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • Research Site
  • Kent
    • Ashford, Kent, United Kingdom, TN24 OLZ
      • Research Site
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Research Site
  • Merseyside
    • Wirral, Merseyside, United Kingdom, CH49 5PE
      • Research Site
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
      • Research Site
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
      • Research Site
  • West Midlands
    • Walsall, West Midlands, United Kingdom, WS2 9PS
      • Research Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Research Site
    • Leeds, West Yorkshire, United Kingdom, LS 9 7TF
      • Research Site
  • Wiltshire
    • Chippenham, Wiltshire, United Kingdom, SN15 2SB
      • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • California
    • La Jolla, California, United States, 92037
      • Research Site
    • Rancho Cucamonga, California, United States, 91730
      • Research Site
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Research Site
  • Georgia
    • Brunswick, Georgia, United States, 31520
      • Research Site
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • Research Site
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48081
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
    • New York, New York, United States, 10029-6574
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Research Site
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Research Site
    • Doylestown, Pennsylvania, United States, 18901
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15240
      • Research Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Research Site
  • Texas
    • Edinburg, Texas, United States, 78539
      • Research Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.
Description of Healthcare resource utilization (HCRU).	Up to 12 months following enrolment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of change in awareness and satisfaction to HK management by patient reported outcome (PRO) at 3 month intervals.	Functional Assessment of Chronic Illness Therapy Treatment Satisfaction-General (FACIT-TS-G) and bespoke questions on dietary recommendations.	Up to 12 months following enrolment.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): December 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Treatment pathways,; Hyperkalemia,; High level of Serum potassium.; Treatment rationale,; Treatment objective,; Treatment expectations,; Heart failure and; Chronic kidney disease.
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: D9480R00048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No