Clinical trial NCT04566653: Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
Official title: Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease & Hyperkalaemia (APPETIZE).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
Keywords: palatability
Lokelma
hyperkalaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Labcorp Corporation of America Holdings, Inc
name: Calyx
name: ERT: Clinical Trial Technology Solutions
name: Medidata Solutions
First posted: 2020-09-28
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dialysis and non-dialysis CKD and HK

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in scores (0-40) for overall palatability of NIMPs
timeFrame: Tasting visit (day 1)
Secondary outcomes:
measure: Difference in scores (0-40) for overall palatability of NIMPs
timeFrame: Tasting visit (day 1)
measure: Difference in scores (0-40) for overall palatability of NIMPs
timeFrame: Tasting visit (day 1)
measure: 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
timeFrame: Tasting visit (day 1)
measure: 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
timeFrame: Tasting visit (day 1)
measure: 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
timeFrame: Tasting visit (day 1)
measure: 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
timeFrame: Tasting Visit (day 1)
measure: 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
timeFrame: Tasting Visit (day 1)
measure: 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
timeFrame: Tasting visit (day 1)
Other outcomes:
measure: See primary and secondary endpoints
timeFrame: Tasting visit (day 1)
measure: See primary and secondary endpoints
timeFrame: Tasting visit (day 1)
measure: Categories or combinations based on Appeal of each attribute (taste, texture, smell, and mouthfeel)
timeFrame: Tasting visit (day 1)
measure: Categories or combinations based on Engagement of each attribute (taste, texture, smell, and mouthfeel)
timeFrame: Tasting visit (day 1)
measure: Categories or combinations based on Empowerment of each attribute (taste, texture, smell, and mouthfeel)
timeFrame: Tasting visit (day 1)
measure: Scoring (0-10) of taste, texture, smell, and mouthfeel
timeFrame: Tasting visit (day 1)
measure: Determining specific feelings regarding taste, texture, smell, and mouthfeel using the AdSAM emotional response model
timeFrame: Tasting visit (day 1)
Locations:
city: Temple Terrace
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Boulogne Billancourt Cedex
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: La Coruña
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Eskilstuna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca, Biopharmaceuticals Medical
name: Eric Wittbrodt, PharmD, MPH
role: STUDY_DIRECTOR
References:
citation: Thomsen RW, Nicolaisen SK, Hasvold P, Sanchez RG, Pedersen L, Adelborg K, Egstrup K, Egfjord M, Sorensen HT. Elevated potassium levels in patients with chronic kidney disease: occurrence, risk factors and clinical outcomes-a Danish population-based cohort study. Nephrol Dial Transplant. 2018 Sep 1;33(9):1610-1620. doi: 10.1093/ndt/gfx312.
citation: Laureati P, Xu Y, Trevisan M, Schalin L, Mariani I, Bellocco R, Sood MM, Barany P, Sjolander A, Evans M, Carrero JJ. Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant. 2020 Sep 1;35(9):1518-1526. doi: 10.1093/ndt/gfz150.
citation: Noel JA, Bota SE, Petrcich W, Garg AX, Carrero JJ, Harel Z, Tangri N, Clark EG, Komenda P, Sood MM. Risk of Hospitalization for Serious Adverse Gastrointestinal Events Associated With Sodium Polystyrene Sulfonate Use in Patients of Advanced Age. JAMA Intern Med. 2019 Aug 1;179(8):1025-1033. doi: 10.1001/jamainternmed.2019.0631.
citation: Zann V, McDermott J, Jacobs JW, Davidson JP, Lin F, Korner P, Blanks RC, Rosenbaum DP. Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate. Drug Des Devel Ther. 2017 Sep 6;11:2663-2673. doi: 10.2147/DDDT.S143461. eCollection 2017.