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Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia

NCT04566653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2023-11-07

No results posted yet for this study

Summary

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 Lokelma® versus Veltassa® versus 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.

Conditions

  • Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure

Interventions

DRUG

Calcium Polystyrene Sulphonate 15g/60 mL water

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

DRUG

Lokelma® 5 g/45mL water

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

DRUG

Lokelma® 10 g/45 mL water

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

DRUG

Veltassa® 8,4 g/80mL water

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

DRUG

Sodium Polystyrene Sulphonate 15g/60 mL water

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Sponsors & Collaborators

  • Labcorp Corporation of America Holdings, Inc

    collaborator INDUSTRY

  • Calyx

    collaborator UNKNOWN

  • ERT: Clinical Trial Technology Solutions

    collaborator OTHER

  • Medidata Solutions

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Eric Wittbrodt, PharmD, MPH · AstraZeneca, Biopharmaceuticals Medical

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-23
Primary Completion
2022-01-12
Completion
2022-01-12

Countries

  • United States
  • Canada
  • France
  • Italy
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566653 on ClinicalTrials.gov