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TRACK: Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05408039
Collaborator
(none)
1,250
Enrollment
81
Locations
24
Anticipated Duration (Months)
15.4
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Non-interventional, Longitudinal Study of the Treatment Journey of Adult Patients With Hyperkalemia
    Actual Study Start Date :
    Jul 14, 2022
    Anticipated Primary Completion Date :
    Jul 15, 2024
    Anticipated Study Completion Date :
    Jul 15, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Description of change in HK management decision at 3 month intervals. [Up to 12 months following enrolment.]

    2. Description of HK management objective(s) decision at 3 month intervals. [Up to 12 months following enrolment.]

    3. Description of expected HK management duration decision at 3 month intervals. [Up to 12 months following enrolment.]

    Secondary Outcome Measures

    1. Change in time to K+ normalization at 3 month intervals. [Up to 12 months following enrolment.]

    2. Description of HK recurrence frequency. [Up to 12 months following enrolment.]

    3. Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy. [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. [Up to 12 months following enrolment.]

    5. Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis. [Up to 12 months following enrolment.]

    6. Description of Healthcare resource utilization (HCRU). [Up to 12 months following enrolment.]

    Other Outcome Measures

    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.]

      Functional Assessment of Chronic Illness Therapy Treatment Satisfaction-General (FACIT-TS-G) and bespoke questions on dietary recommendations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    • Age ≥18 years on the date of study enrollment.

    • HK with K+ level(s) > 5.0 mmol/l collected during Standard of Care, within 14 days prior to the date of recruitment.

    • Provision of signed and dated informed consent.

    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.

    • Renal transplant anticipated or planned during the study period.

    • Involvement in the planning and/or conduct of the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Rancho Cucamonga California United States 91730
    2 Research Site Denver Colorado United States 80230
    3 Research Site Fairfield Connecticut United States 06824
    4 Research Site Washington District of Columbia United States 20037
    5 Research Site Lauderdale Lakes Florida United States 33313
    6 Research Site Caldwell Idaho United States 836035
    7 Research Site Oak Brook Illinois United States 60523
    8 Research Site Saint Clair Shores Michigan United States 48081
    9 Research Site Albany New York United States 12208
    10 Research Site Pittsburgh Pennsylvania United States 15240
    11 Research Site East Providence Rhode Island United States 02915
    12 Research Site San Antonio Texas United States 78215
    13 Research Site Bad Krozingen Baden Wuerttemberg Germany 79189
    14 Research Site Heilbronn Baden Wuerttemberg Germany 74076
    15 Research Site Stuttgart Baden Wuerttemberg Germany 70376
    16 Research Site Coburg Bayern Germany 96450
    17 Research Site Goettingen Niedersachsen Germany 37075
    18 Research Site Kiel Schleswig Holstein Germany 24105
    19 Research Site Luebeck Schleswig Holstein Germany 23538
    20 Research Site Berlin Germany 10117
    21 Research Site Berlin Germany 10365
    22 Research Site Berlin Germany 10559
    23 Research Site Berlin Germany 10789
    24 Research Site Berlin Germany 12200
    25 Research Site Hamburg Germany 20099
    26 Research Site Torrette Di Ancona Ancona Italy 60126
    27 Research Site San Giovanni Rotondo Foggia Italy 71013
    28 Research Site Rozzano Milano Italy 20089
    29 Research Site Padova PD Padova Italy 35122
    30 Research Site Avellino Italy 83100
    31 Research Site Bari Italy 70124
    32 Research Site Bologna Italy 40138
    33 Research Site Brescia Italy 25123
    34 Research Site Catanzaro Italy 88100
    35 Research Site Chieti Italy 66013
    36 Research Site Firenze Italy 50134
    37 Research Site Firenze Italy 50143
    38 Research Site Genova Italy 16132
    39 Research Site Lecco Italy 23900
    40 Research Site Messina Italy 98124
    41 Research Site Milano Italy 20157
    42 Research Site Milano Italy 20158
    43 Research Site Napoli Italy 80131
    44 Research Site Napoli Italy 80138
    45 Research Site Parma Italy 43100
    46 Research Site Pavia Italy 27100
    47 Research Site Pisa Italy 56126
    48 Research Site Roma Italy 00137
    49 Research Site Roma Italy 00163
    50 Research Site Salerno Italy 84100
    51 Research Site Trieste Italy 34100
    52 Research Site Gijon Asturias Spain 33206
    53 Research Site Badalona Barcelona Spain 08916
    54 Research Site Sant Joan Despi Barcelona Spain 08970
    55 Research Site Garanada Granada Spain 18016
    56 Research Site Jaen Jaén Spain 23007
    57 Research Site Ferrol La Coruña Spain 15405
    58 Research Site Majadahonda Madrid Spain 28222
    59 Research Site San Sebastian de los Reyes Madrid Spain 28702
    60 Research Site El Palmar Murcia Spain 30120
    61 Research Site Barcelona Spain 08907
    62 Research Site Girona Spain 17007
    63 Research Site Madrid Spain 28040
    64 Research Site Madrid Spain 28046
    65 Research Site Salamanca Spain 37007
    66 Research Site Valencia Spain 46010
    67 Research Site Zaragoza Spain 50009
    68 Research Site Bristol Avon United Kingdom BS10 5NB
    69 Research Site Barnstaple Devon United Kingdom EX31 4JB
    70 Research Site Exeter Devon United Kingdom EX2 5DW
    71 Research Site Plymouth Devon United Kingdom PL6 8BQ
    72 Research Site Hull East Riding Of Yorkshire United Kingdom HU3 2JZ
    73 Research Site London Greater London United Kingdom E1 1BB
    74 Research Site London Greater London United Kingdom SW17 0QT
    75 Research Site London Greater London United Kingdom W12 0HS
    76 Research Site Salford Greater Manchester United Kingdom M6 8HD
    77 Research Site Barnet Hertfordshire United Kingdom EN5 3DJ
    78 Research Site Preston Lancashire United Kingdom PR2 9HT
    79 Research Site Leicester Leicestershire United Kingdom LE5 4PW
    80 Research Site Nottingham Nottinghamshire United Kingdom NG5 1PB
    81 Research Site Chippenham Wiltshire United Kingdom SN15 2SB

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05408039
    Other Study ID Numbers:
    • D9480R00048
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Treatment pathways,
    Hyperkalemia,
    High level of Serum potassium.
    Treatment rationale,
    Treatment objective,
    Treatment expectations,
    Heart failure and
    Chronic kidney disease.
    Additional relevant MeSH terms:
    Hyperkalemia

    Study Results

    No Results Posted as of Aug 3, 2022