Clinical trial NCT05408039: Tracking Treatment Pathways in Adult Patients With Hyperkalemia.
Official title: A Prospective, Non-interventional, Longitudinal Study of the Treatment Journey of Adult Patients With Hyperkalemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperkalemia
Keywords: Treatment pathways,
Hyperkalemia,
High level of Serum potassium.
Treatment rationale,
Treatment objective,
Treatment expectations,
Heart failure and
Chronic kidney disease.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 1331
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Description of change in HK management decision at 3 month intervals.
timeFrame: Up to 12 months following enrolment.
measure: Description of HK management objective(s) decision at 3 month intervals.
timeFrame: Up to 12 months following enrolment.
measure: Description of expected HK management duration decision at 3 month intervals.
timeFrame: Up to 12 months following enrolment.
Secondary outcomes:
measure: Change in time to K+ normalization at 3 month intervals.
timeFrame: Up to 12 months following enrolment.
measure: Description of HK recurrence frequency.
timeFrame: Up to 12 months following enrolment.
measure: Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy.
timeFrame: Up to 12 months following enrolment.
measure: Change in time to achieve target dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy at 3 month intervals.
timeFrame: Up to 12 months following enrolment.
measure: Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis.
timeFrame: Up to 12 months following enrolment.
measure: Description of Healthcare resource utilization (HCRU).
timeFrame: Up to 12 months following enrolment.
Other outcomes:
measure: Description of change in awareness and satisfaction to HK management by patient reported outcome (PRO) at 3 month intervals.
timeFrame: Up to 12 months following enrolment.
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: La Jolla
country: United States
facility: Research Site
state: California
city: Rancho Cucamonga
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Nampa
country: United States
facility: Research Site
state: Idaho
city: Hinsdale
country: United States
facility: Research Site
state: Illinois
city: Princeton
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Abington
country: United States
facility: Research Site
state: Pennsylvania
city: Doylestown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Edinburg
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Bad Krozingen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Goettingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Papenburg
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Lecco
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: El Ejido
country: Spain
facility: Research Site
city: El Palmar
country: Spain
facility: Research Site
city: Ferrol
country: Spain
facility: Research Site
city: Gij N
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Ja N
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: San Sebasti N De Los Reyes
country: Spain
facility: Research Site
city: Sant Joan Despi
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Ashford
country: United Kingdom
facility: Research Site
city: Barnet
country: United Kingdom
facility: Research Site
city: Barnstaple
country: United Kingdom
facility: Research Site
city: Birkenhead
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Calow
country: United Kingdom
facility: Research Site
city: Dorchester
country: United Kingdom
facility: Research Site
city: Headington
country: United Kingdom
facility: Research Site
city: High Heaton/Newcastle Upon Tyn
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Kogarah
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Preston
country: United Kingdom
facility: Research Site
city: Salford
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
Study officials:
References: