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Tracking Treatment Pathways in Adult Patients With Hyperkalemia.
Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

NCT05408039

CompletedN/A

Sponsor: AstraZeneca

Conditions: Hyperkalemia

Countries: United States, Germany, Italy, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (74)
  • Huntsville, Alabama, United States
  • La Jolla, California, United States
  • Rancho Cucamonga, California, United States
  • New Haven, Connecticut, United States
  • Nampa, Idaho, United States
  • Hinsdale, Illinois, United States
  • Princeton, New Jersey, United States
  • Albany, New York, United States
  • New York, New York, United States
  • Abington, Pennsylvania, United States
  • Doylestown, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Edinburg, Texas, United States
  • Houston, Texas, United States
  • Burlington, Vermont, United States
  • Bad Krozingen, Germany
  • Berlin, Germany
  • Coburg, Germany
  • Dresden, Germany
  • Fulda, Germany
  • Göttingen, Germany
  • Halle, Germany
  • Papenburg, Germany
  • Stuttgart, Germany
  • Bari, Italy
  • Bologna, Italy
  • Brescia, Italy
  • Catanzaro, Italy
  • + 44 more on CT.gov