Recruitment

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