Patient Palatability and Preference of 3 Potassium Binders in Patients with Chronic Kidney Disease and Hyperkalaemia - APPETIZE

Study identifier:D9480C00016

ClinicalTrials.gov identifier:NCT04566653

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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).

Medical condition

chronic kidney disease + hyperkalaemia +/- heart failure

Phase

Phase 4

Healthy volunteers

Study drug

Calcium Polystyrene Sulphonate 15g/60 mL water, Lokelma® 5 g/45mL water, Lokelma® 10 g/45 mL water, Veltassa® 8,4 g/80mL water, Sodium Polystyrene Sulphonate 15g/60 mL water

Sex

All

Actual Enrollment

147

Study type

Observational

Age

18 Years - 130 Years

Date

Study Start Date: 23 Oct 2020

Primary Completion Date: 12 Jan 2022

Study Completion Date: 12 Jan 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: -

Verification:

Verified 01 Nov 2023 by AstraZeneca

Collaborators

Labcorp Drug Development Inc., Calyx, ERT, Medidata

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
dialysis-dependent chronic kidney disease patients with hyperkalaemia and dialysis-dependent	Drug: Calcium Polystyrene Sulphonate 15g/60 mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test) Drug: Lokelma® 5 g/45mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test) Drug: Veltassa® 8,4 g/80mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test) Drug: Sodium Polystyrene Sulphonate 15g/60 mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test)
non-dialysis-dependent chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent	Drug: Calcium Polystyrene Sulphonate 15g/60 mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test) Drug: Lokelma® 10 g/45 mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test) Drug: Veltassa® 8,4 g/80mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test) Drug: Sodium Polystyrene Sulphonate 15g/60 mL water K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Arms

Assigned Interventions

dialysis-dependent
chronic kidney disease patients with hyperkalaemia and dialysis-dependent

Drug: Calcium Polystyrene Sulphonate 15g/60 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Drug: Lokelma® 5 g/45mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Drug: Veltassa® 8,4 g/80mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Drug: Sodium Polystyrene Sulphonate 15g/60 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

non-dialysis-dependent
chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent

Drug: Calcium Polystyrene Sulphonate 15g/60 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Drug: Lokelma® 10 g/45 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Drug: Veltassa® 8,4 g/80mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Drug: Sodium Polystyrene Sulphonate 15g/60 mL water
K+ binder, not for treatment but for tasting (sip-and-spit taste test)

Documents available

AdSAM Emotional Response Modelling website. AdSAM Measure.
Download
Gasparini A, Evans M, Barany P, Xu H, Jernberg T, Ärnlöv J, et al. Plasma potassium ranges associated with mortality across stages of chronic kidney disease: the Stockholm CREAtinine Measurements (SCREAM) project. Nephrol Dial Transplant. 2018;(Aug):1–8.
Download
Ingelfinger JR. A new era for the treatment of hyperkalemia? N Engl J Med [Internet]. 2015 Jan 15;372(3):275–7.
Download
Kovesdy CP. Management of hyperkalemia: An update for the internist [Internet]. Vol. 128, American Journal of Medicine. Elsevier; 2015 [cited 2019 Feb 18]. p. 1281–7.
Download
Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, et al. Sodium Zirconium Cyclosilicate in Hyperkalemia. N Engl J Med [Internet]. 2015;372(3):222–31.
Download
Stokes JR, Boehm MW, Baier SK. Oral processing, texture and mouthfeel: From rheology to tribology and beyond. Curr Opin Colloid Interface Sci [Internet]. 2013;18(4):349–59.
Download
Guinard JX, Mazzucchelli R. The sensory perception of texture and mouthfeel. Trends Food Sci Technol. 1996;7(7):213–9
Download
Morris JD, Woo C, Geason JA, and Kim J. The power of affect: predicting intention. Journal of Advertising Research. 2002;42(3):7-17.
Download
CSR synopsis redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Eric Wittbrodt

AstraZeneca, Biopharmaceuticals Medical

Patient Palatability and Preference of 3 Potassium Binders in Patients with Chronic Kidney Disease and Hyperkalaemia - APPETIZE

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

AdSAM Emotional Response Modelling website. AdSAM Measure.

Gasparini A, Evans M, Barany P, Xu H, Jernberg T, Ärnlöv J, et al. Plasma potassium ranges associated with mortality across stages of chronic kidney disease: the Stockholm CREAtinine Measurements (SCREAM) project. Nephrol Dial Transplant. 2018;(Aug):1–8.

Ingelfinger JR. A new era for the treatment of hyperkalemia? N Engl J Med [Internet]. 2015 Jan 15;372(3):275–7.

Kovesdy CP. Management of hyperkalemia: An update for the internist [Internet]. Vol. 128, American Journal of Medicine. Elsevier; 2015 [cited 2019 Feb 18]. p. 1281–7.

Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, et al. Sodium Zirconium Cyclosilicate in Hyperkalemia. N Engl J Med [Internet]. 2015;372(3):222–31.

Stokes JR, Boehm MW, Baier SK. Oral processing, texture and mouthfeel: From rheology to tribology and beyond. Curr Opin Colloid Interface Sci [Internet]. 2013;18(4):349–59.

Guinard JX, Mazzucchelli R. The sensory perception of texture and mouthfeel. Trends Food Sci Technol. 1996;7(7):213–9

Morris JD, Woo C, Geason JA, and Kim J. The power of affect: predicting intention. Journal of Advertising Research. 2002;42(3):7-17.

CSR synopsis redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator