NCT05408039Completed
Tracking Treatment Pathways in Adult Patients With Hyperkalemia.
A Prospective, Non-interventional, Longitudinal Study of the Treatment Journey of Adult Patients With Hyperkalemia
Source: ClinicalTrials.gov · Last updated 15 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1331 (actual)
- First submitted
- 18 May 2022
- Start date
- 14 Jul 2022
- Primary completion date
- 19 Dec 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT05408039
What you commit to
- Study type: Observational
- Participants enrolled: 1331
- From 14 Jul 2022 to the primary completion date, 19 Dec 2024
- 74 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patients meeting all the following inclusion criteria will be eligible for inclusion into the study:
- Age ≥18 years on the date of signing informed consent
- 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\*
- 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:
- 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
- Scheduled renal transplant
- Involvement in the planning and/or conduct of the study
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (74)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Hyperkalemia Management in the US Cohort of the Prospective, Observational, Real-World TRACK Study.Adv Ther · 2026 · PMID 42627452
This page is information, not medical advice. Discuss any trial with your doctor.