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

AstraZeneca

Status

Completed

Conditions

Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure

Treatments

Drug: Calcium Polystyrene Sulphonate 15g/60 mL water

Drug: Lokelma® 5 g/45mL water

Drug: Sodium Polystyrene Sulphonate 15g/60 mL water

Drug: Lokelma® 10 g/45 mL water

Drug: Veltassa® 8,4 g/80mL water

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04566653

D9480C00016

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

147 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.