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

Completed

Conditions studied: Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure

In brief

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.

Key facts

Study ID: NCT04566653
Run by: AstraZeneca
People needed: 147
Starts: 2020-10-23
Expected to finish: 2022-01-12
Last updated by the study team: 2023-11-07

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must be adults aged ≥18 years, at the time of signing the informed consent.
Participants should have CKD defined by having an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated using CKD-EPI equation) measured twice at least 90 days apart. (The eGFR should be measured when the participant is considered to be in a steady state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs, aminoglycosides, co-trimoxazole), or changes in dietary protein intake.)
Prevalent HK with serum K+ >5 mmol/L.
Male and/or female
Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Informed consent must be obtained prior to any study-specific procedures performed.

You may not qualify if…

Screening serum K+ value which, in the opinion of the investigator, requires immediate medical intervention (ie, cannot wait until after tasting procedures).
As judged by the investigator, any evidence of any condition which in the investigator's opinion makes it undesirable for the participant to participate in the study.
Known history of drug or alcohol abuse within 6 months of screening.
History of QT prolongation associated with other medications that required discontinuation of that medication, including congenital long QT syndrome.
Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
Have a life expectancy of <6 months.
12-lead ECG with reported QTcF >550 msec at screening.
Are current smoker.
Have mouth ulcers/mouth infection, respiratory infection, nasal congestion, or other condition, medication, or procedure which may interfere with sense of smell or taste, in opinion of the investigator.
Participants currently prescribed a K+ binder at time of screening/enrolment.
Participants unable to hold other oral medications from 3 hours prior to the start of tasting through 3 hours after the end of tasting.
Current participation or participation within the previous 28 days in another clinical study with an investigational product administered.
Participants with a known hypersensitivity to Lokelma, Veltassa, or S/CPS or any of the excipients of the NIMPs.
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
Previous enrolment or randomisation in the present study.
For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
Participants unable to read the local language and therefore unable to complete the questionnaires.

Where it is running

Research Site — Temple Terrace, Florida, United States
Research Site — West Palm Beach, Florida, United States
Research Site — Toronto, Ontario, Canada
Research Site — Greenfield Park, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Québec, Quebec, Canada
Research Site — Amiens, France
Research Site — Boulogne-Billancourt, France
Research Site — Nice, France
Research Site — Genova, Italy
Research Site — Parma, Italy
Research Site — Pavia, Italy
Research Site — A Coruña, Spain
Research Site — Barcelona, Spain
Research Site — Córdoba, Spain
Research Site — Madrid, Spain
Research Site — Eskilstuna, Sweden
Research Site — Stockholm, Sweden

Full record on ClinicalTrials.gov

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