Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
Conditions
Keywords
palatability, Lokelma, hyperkalaemia
Brief 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.
Detailed 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.
Interventions
DRUGCalcium Polystyrene Sulphonate 15g/60 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
DRUGLokelma® 5 g/45mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
DRUGLokelma® 10 g/45 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
DRUGVeltassa® 8,4 g/80mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
DRUGSodium Polystyrene Sulphonate 15g/60 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
Sponsors
Labcorp Corporation of America Holdings, Inc
Calyx
ERT: Clinical Trial Technology Solutions
Medidata Solutions
AstraZeneca
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must be adults aged ≥18 years, at the time of signing the informed consent. 2. 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.) 3. Prevalent HK with serum K+ \>5 mmol/L. 4. Male and/or female 5. 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
1. Screening serum K+ value which, in the opinion of the investigator, requires immediate medical intervention (ie, cannot wait until after tasting procedures). 2. 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. 3. Known history of drug or alcohol abuse within 6 months of screening. 4. History of QT prolongation associated with other medications that required discontinuation of that medication, including congenital long QT syndrome. 5. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted. 6. Have a life expectancy of \<6 months. 7. 12-lead ECG with reported QTcF \>550 msec at screening. 8. Are current smoker. 9. 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. 10. Participants currently prescribed a K+ binder at time of screening/enrolment. 11. Participants unable to hold other oral medications from 3 hours prior to the start of tasting through 3 hours after the end of tasting. 12. Current participation or participation within the previous 28 days in another clinical study with an investigational product administered. 13. Participants with a known hypersensitivity to Lokelma, Veltassa, or S/CPS or any of the excipients of the NIMPs. 14. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 15. 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. 16. Previous enrolment or randomisation in the present study. 17. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding. 18. Participants unable to read the local language and therefore unable to complete the questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in scores (0-40) for overall palatability of NIMPs | Tasting visit (day 1) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in scores (0-40) for overall palatability of NIMPs | Tasting visit (day 1) | To compare patient-reported overall palatability (composite of taste, texture, smell, and mouthfeel) between Lokelma and Veltassa, and between Lokelma and S/CPS in Canada |
| Difference in scores for feelings of Appeal (4-36), Engagement (4-36), and Empowerment (4-36) regarding taste overall palatability of NIMPs using the AdSAM emotional response tool | Tasting visit (day 1) | To compare patient-reported emotional response to overall palatability (composite of taste, texture, smell, and mouthfeel) taste between Lokelma and Veltassa, and between Lokelma and S/CPS in the US |
| Difference in scores for feelings of appeal (4-36), engagement (4-36), and empowerment (4-36) regarding overall palatability of NIMPs using the AdSAM emotional response tool | Tasting visit (day 1) | To compare patient-reported emotional response to overall palatability (composite of taste, texture, smell, and mouthfeel) between Lokelma and Veltassa, and between Lokelma and S/CPS in Canada |
| Scoring of palatability (0-40), Appeal of palatability (4-36), Engagement of palatability (4-36), Empowerment of palatability (4-36), Overall composite emotional strength indicator scores (0-1200), Feelings towards palatability | Tasting Visit (day 1) | To describe patient-reported preference for overall palatability (composite of taste, texture, smell, and mouthfeel) (scoring and non-verbal emotional response for how each NIMP made patients feel ofto each NIMP) of 3 currently marketed K+ binders ((of Lokelma, Veltassa, and S/CPS) in the US, Canada, and EU, respectively) |
| Scoring (0-10), Appeal (9-1), Engagement (9-1), Empowerment (1-9), Overall emotional strength indicator score (0-300), and Feelings towards willingness to take a K+ binder | Tasting Visit (day 1) | To describe and compare, based on the overall palatability experience, scoring and emotional response for how willing patients would be to take each K+ binder to help manage their serum potassium (likelihood of adherence) in the US, Canada, and EU |
| Overall preference ranking of NIMPs (1, 2, or 3) of Lokelma, Veltassa, and S/CPS • Use of Comparative AdSAM Emotional Strength Index and Emotional TempIndicator scores to derive overall preference | Tasting visit (day 1) | To describe patient-reported preference by ranking the NIMPs, and derived preference based on the emotional strength indexindicator scores in the US, Canada, and EU |
Other
| Measure | Time frame | Description |
|---|---|---|
| Categories or combinations based on Appeal of each attribute (taste, texture, smell, and mouthfeel) | Tasting visit (day 1) | Appeal test score (1-9) for each attribute (taste, texture, smell, and mouthfeel) will be measured using AdSAM questionnaires using published research and analysed using AdSAM methodology and compare between Lokelma and Veltassa, and between Lokelma and S/CPS for the US, Canada, EU, North America, per individual EU countries (where data permit), and over all countries/regions. |
| Categories or combinations based on Engagement of each attribute (taste, texture, smell, and mouthfeel) | Tasting visit (day 1) | Engagement test score (1-9) for each attribute (taste, texture, smell, and mouthfeel) will be measured using AdSAM questionnaires team using published research and analysed using AdSAM methodology and compare between Lokelma and Veltassa, and between Lokelma and S/CPS for the US, Canada, EU, North America, per individual EU countries (where data permit), and over all countries/regions |
| Categories or combinations based on Empowerment of each attribute (taste, texture, smell, and mouthfeel) | Tasting visit (day 1) | Empowerment test score (1-9) for each attribute (taste, texture, smell, and mouthfeel) will be measured using AdSAM questionnaires team using published research and analysed using AdSAM methodology and compare between Lokelma and Veltassa, and between Lokelma and S/CPS for the US, Canada, EU, North America, per individual EU countries (where data permit), and over all countries/regions |
| Scoring (0-10) of taste, texture, smell, and mouthfeel | Tasting visit (day 1) | Scores of individual palatability attributes (taste, texture, smell, and mouthfeel) will be described individually by countries/regions |
| Determining specific feelings regarding taste, texture, smell, and mouthfeel using the AdSAM emotional response model | Tasting visit (day 1) | Emotional response of individual palatability attributes (taste, texture, smell, and mouthfeel) will be described individually by countries/regions |
| See primary and secondary endpoints | Tasting visit (day 1) | Overall palatability scores (0-40) between Lokelma and Veltassa, and between Lokelma and S/CPS will be described and compared for all primary and secondary endpoints for: North America, per individual EU countries (where data permit), and over all countries/regions |
Countries
Canada, France, Italy, Spain, Sweden, United States
Outcome results
None listed