Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders, Sodium Polystyrene Sulphonate (SPS) or Calcium Polystyrene Sulphonate (CPS), Sodium Zirconium Cyclosilicate (Lokelma®), and Calcium Patiromer Sorbitex (Veltassa®) in Patients with Chronic Kidney Disease and Hyperkalaemia (APPETIZE)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Patient taste preference
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Phase IV, exploratory, cross-over, active comparator controlled study

Study drug and medical condition

• Name of medicine:
  LOKELMA

  VELTASSA
• Anatomical Therapeutic Chemical (ATC) code:
  (V03AE01) polystyrene sulfonate

  polystyrene sulfonate
• Medical condition to be studied:
  Chronic kidney disease

  Hyperkalaemia

Population studied

• Short description of the study population:
  The study subjects were patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK) aged 18 years or older treated with sodium zirconium cyclosilicate (Lokelma®), calcium patiromer sorbitex (Veltassa®), sodium polystyrene sulphonate and calcium polystyrene sulphonate (CPS).; 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; • 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
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  148

Study design details

• Main study objective:
  To compare patient-reported overall taste between Lokelma and Veltassa, and between Lokelma and S/CPS
• Outcomes:
  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), To compare: patient-reported overall palatability, between Lokelma & Veltassa, and between Lokelma & S/CPS, patient-reported emotional response to overall palatability, between Lokelma & Veltassa, & between Lokelma and S/CPS. To describe and compare scoring & emotional response for how willing patients would be to take each K+ binder, describe patient-reported preference by ranking the NIMPs.
• Data analysis plan:
  The primary endpoint is the overall Scoring (0-10) of taste. The primary analysis is to compare the scoring between Lokelma and Veltassa, and between Lokelma and S/CPS. The null hypotheses (H0) are that the oveThe primary endpoint is the overall palatability Scoring (0-40), a composite score of taste, texture, smell, and mouthfeel. The primary analysis is to compare the scoring between Lokelma and Veltassa, and between Lokelma and S/CPS in the US. AstraZeneca hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma, when compared with Veltassa and S/CPS. Additionally, emotional response scores (towards appeal, engagement and empowerment) will score higher (better) for Lokelma, when compared with Veltassa and S/CPS. Each objective will be analysed per country/region. In addition, the difference in results per regions and overall may be explored as outlined in the Study Objectives.

Documents

Study results

APPETIZE Abstract_04Nov2022