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NCT04566653 · ClinicalTrials.gov registry record
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 147
- Enrollment target
NCT04566653: Completed study, sponsored by AstraZeneca.
NCT04566653 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 147 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04566653 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 147 participants
- Enrollment target
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.
Primary Outcome
To compare patient-reported overall palatability (composite of taste, texture, smell, and mouthfeel) between Lokelma and Veltassa, and between Lokelma and S/CPS in the United States (US)
Interventions
- DRUG Calcium Polystyrene Sulphonate 15g/60 mL water
- DRUG Lokelma® 5 g/45mL water
- DRUG Lokelma® 10 g/45 mL water
- DRUG Veltassa® 8,4 g/80mL water
- DRUG Sodium Polystyrene Sulphonate 15g/60 mL water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2022-01-12 |
What the finished NCT04566653 record still lists
NCT04566653 is an observational study that tracks outcomes without assigning an intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Calcium Polystyrene Sulphonate 15g/60 mL water is the first listed.
NCT04566653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04566653 about?
NCT04566653 is a clinical study titled "Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia". 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 ...
What is the current status of trial NCT04566653?
This trial is currently completed. The enrollment target is 147 participants. The study started on 2020-10-23. Estimated completion is 2022-01-12.
What interventions are being tested in trial NCT04566653?
The interventions under investigation include: Calcium Polystyrene Sulphonate 15g/60 mL water (DRUG), Lokelma® 5 g/45mL water (DRUG), Lokelma® 10 g/45 mL water (DRUG), Veltassa® 8,4 g/80mL water (DRUG), Sodium Polystyrene Sulphonate 15g/60 mL water (DRUG).
Who is sponsoring clinical trial NCT04566653?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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