Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

Hyperkalemia Clinical Trial

— TRACK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05408039
• Other study ID #: D9480R00048
• Status: Active, not recruiting
• Start date: July 14, 2022
• Est. completion date: December 16, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1297
• Est. completion date: December 16, 2024
• Est. primary completion date: December 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperkalemia

Locations

Country	Name	City	State
Germany	Research Site	Bad Krozingen	Baden Wuerttemberg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Dresden	Sachsen
Germany	Research Site	Erfurt	Thueringen
Germany	Research Site	Fulda	Hessen
Germany	Research Site	Goettingen	Niedersachsen
Germany	Research Site	Halle	Sachsen Anhalt
Germany	Research Site	Heilbronn	Baden Wuerttemberg
Germany	Research Site	Kiel	Schleswig Holstein
Germany	Research Site	Luebeck	Schleswig Holstein
Germany	Research Site	Papenburg	Niedersachsen
Germany	Research Site	Stuttgart	Baden Wuerttemberg
Italy	Research Site	Avellino
Italy	Research Site	Bari
Italy	Research Site	Bologna
Italy	Research Site	Brescia
Italy	Research Site	Catanzaro
Italy	Research Site	Chieti
Italy	Research Site	Firenze
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	Lecco
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Napoli
Italy	Research Site	Padova PD	Padova
Italy	Research Site	Parma
Italy	Research Site	Pavia
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Rozzano	Milano
Italy	Research Site	San Giovanni Rotondo	Foggia
Italy	Research Site	Torrette Di Ancona	Ancona
Italy	Research Site	Trieste
Italy	Research Site	Verona
Spain	Research Site	Badalona	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	El Ejido	Almeria
Spain	Research Site	El Palmar	Murcia
Spain	Research Site	Ferrol	La Coruna
Spain	Research Site	Gijon	Asturias
Spain	Research Site	Girona
Spain	Research Site	Granada
Spain	Research Site	Jaen
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda	Madrid
Spain	Research Site	Salamanca
Spain	Research Site	San Sebastian de los Reyes	Madrid
Spain	Research Site	Sant Joan Despi	Barcelona
Spain	Research Site	Zaragoza
United Kingdom	Research Site	Ashford	Kent
United Kingdom	Research Site	Barnet	Hertfordshire
United Kingdom	Research Site	Bradford	West Yorkshire
United Kingdom	Research Site	Bristol	Avon
United Kingdom	Research Site	Chesterfield	Derbyshire
United Kingdom	Research Site	Chippenham	Wiltshire
United Kingdom	Research Site	Dorchester	Dorset
United Kingdom	Research Site	Hull	East Riding Of Yorkshire
United Kingdom	Research Site	Leeds	West Yorkshire
United Kingdom	Research Site	London	Greater London
United Kingdom	Research Site	London	Greater London
United Kingdom	Research Site	London	Greater London
United Kingdom	Research Site	Newcastle upon Tyne	Tyne And Wear
United Kingdom	Research Site	Oxford	Oxfordshire
United Kingdom	Research Site	Plymouth	Devon
United Kingdom	Research Site	Preston	Lancashire
United Kingdom	Research Site	Salford	Greater Manchester
United Kingdom	Research Site	Stevenage	Hertfordshire
United Kingdom	Research Site	Walsall	West Midlands
United Kingdom	Research Site	Wirral	Merseyside
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Albany	New York
United States	Research Site	Brunswick	Georgia
United States	Research Site	Burlington	Vermont
United States	Research Site	Doylestown	Pennsylvania
United States	Research Site	Durham	North Carolina
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Edinburg	Texas
United States	Research Site	Fairfield	Connecticut
United States	Research Site	Huntsville	Alabama
United States	Research Site	La Jolla	California
United States	Research Site	New York	New York
United States	Research Site	Oak Brook	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Rancho Cucamonga	California
United States	Research Site	Saint Clair Shores	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	Description of change in HK management decision at 3 month intervals.		Up to 12 months following enrolment.
Primary	Description of HK management objective(s) decision at 3 month intervals.		Up to 12 months following enrolment.
Primary	Description of expected HK management duration decision at 3 month intervals.		Up to 12 months following enrolment.
Secondary	Change in time to K+ normalization at 3 month intervals.		Up to 12 months following enrolment.
Secondary	Description of HK recurrence frequency.		Up to 12 months following enrolment.
Secondary	Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy.		Up to 12 months following enrolment.
Secondary	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.
Secondary	Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis.		Up to 12 months following enrolment.
Secondary	Description of Healthcare resource utilization (HCRU).		Up to 12 months following enrolment.