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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.
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.
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| Measure | Description | 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. |
| Measure | Description | 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. | |
| 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. |
Patients meeting all the following inclusion criteria will be eligible for inclusion into the study:
(*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:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | 35805 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39464260 | Derived | 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. |
| Label | URL |
|---|---|
| D9480R00048 CSR Synopsis Redacted | View source |
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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.
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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.
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.
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Not applicable. No Samples Retained
| 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. |
| La Jolla |
| California |
| 92037 |
| United States |
| Research Site | Rancho Cucamonga | California | 91730 | United States |
| Research Site | New Haven | Connecticut | 06511 | United States |
| Research Site | Nampa | Idaho | 83687 | United States |
| Research Site | Hinsdale | Illinois | 60521 | United States |
| Research Site | Princeton | New Jersey | 08540 | United States |
| Research Site | Albany | New York | 12208 | United States |
| Research Site | New York | New York | 10011 | United States |
| Research Site | Abington | Pennsylvania | 19001 | United States |
| Research Site | Doylestown | Pennsylvania | 18901 | United States |
| Research Site | Philadelphia | Pennsylvania | 19140 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Research Site | Providence | Rhode Island | 02903 | United States |
| Research Site | Edinburg | Texas | 78539 | United States |
| Research Site | Houston | Texas | 77089 | United States |
| Research Site | Burlington | Vermont | 05401 | United States |
| Research Site | Bad Krozingen | Germany |
| Research Site | Berlin | Germany |
| Research Site | Coburg | Germany |
| Research Site | Dresden | Germany |
| Research Site | Fulda | Germany |
| Research Site | Göttingen | Germany |
| Research Site | Halle | Germany |
| Research Site | Papenburg | Germany |
| Research Site | Stuttgart | Germany |
| Research Site | Bari | Italy |
| Research Site | Bologna | Italy |
| Research Site | Brescia | Italy |
| Research Site | Catanzaro | Italy |
| Research Site | Florence | Italy |
| Research Site | Genova | Italy |
| Research Site | Lecco | Italy |
| Research Site | Milan | Italy |
| Research Site | Naples | Italy |
| Research Site | Padova | Italy |
| Research Site | Parma | Italy |
| Research Site | Pisa | Italy |
| Research Site | Rome | Italy |
| Research Site | Rozzano | Italy |
| Research Site | San Giovanni Rotondo | Italy |
| Research Site | Sassari | Italy |
| Research Site | Trieste | Italy |
| Research Site | Badalona | Spain |
| Research Site | Barcelona | Spain |
| Research Site | El Ejido | Spain |
| Research Site | El Palmar | Spain |
| Research Site | Ferrol | Spain |
| Research Site | Gij N | Spain |
| Research Site | Girona | Spain |
| Research Site | Granada | Spain |
| Research Site | Ja N | Spain |
| Research Site | Madrid | Spain |
| Research Site | Majadahonda | Spain |
| Research Site | Salamanca | Spain |
| Research Site | San Sebasti N de Los Reyes | Spain |
| Research Site | Sant Joan DespĂ | Spain |
| Research Site | Zaragoza | Spain |
| Research Site | Ashford | United Kingdom |
| Research Site | Barnet | United Kingdom |
| Research Site | Barnstaple | United Kingdom |
| Research Site | Birkenhead | United Kingdom |
| Research Site | Bradford | United Kingdom |
| Research Site | Bristol | United Kingdom |
| Research Site | Calow | United Kingdom |
| Research Site | Dorchester | United Kingdom |
| Research Site | Headington | United Kingdom |
| Research Site | High Heaton/Newcastle Upon Tyn | United Kingdom |
| Research Site | Hull | United Kingdom |
| Research Site | Kogarah | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Preston | United Kingdom |
| Research Site | Salford | United Kingdom |
| Research Site | Stevenage | United Kingdom |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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