An observational study in Hyperkalemia, sponsored by AstraZeneca. Completed at 74 sites in 5 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by AstraZeneca · Observational
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:
The secondary objective:
The exploratory objective:
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.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 1,331 is above the median of 459 across 30 observational studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Description of change in HK management decision at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Description of HK management objective(s) decision at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Description of expected HK management duration decision at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Change in time to K+ normalization at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Description of HK recurrence frequency.
Time frame: Up to 12 months following enrolment.
Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy.
Time frame: 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.
Time frame: Up to 12 months following enrolment.
Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis.
Time frame: Up to 12 months following enrolment.
Description of Healthcare resource utilization (HCRU).
Time frame: Up to 12 months following enrolment.
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.
Time frame: Up to 12 months following enrolment.
Plan to share: Yes — 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.
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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