Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 420
Summary
- Conditions
- Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Between 18 years and 130 years
- Gender
- Both males and females
Description
This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of sodium zirconium cyclosilicate (hereafter referred to as Lokelma®) versus calcium patiromer sorbitex (hereafter ref...
This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of sodium zirconium cyclosilicate (hereafter referred to as Lokelma®) versus calcium patiromer sorbitex (hereafter referred to as Veltassa®) versus sodium polystyrene sulphonate (SPS) or calcium polystyrene sulphonate (CPS) (hereafter referred to as S/CPS) in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS. Each objective will be analysed per country. In addition, the difference in results per regions and overall may be explored.
Tracking Information
- NCT #
- NCT04566653
- Collaborators
- Covance
- Calyx
- ERT: Clinical Trial Technology Solutions
- Medidata Solutions
- Investigators
- Study Director: Eric Wittbrodt, PharmD, MPH AstraZeneca, Biopharmaceuticals Medical