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).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Difference in scores (0-40) for overall palatability of NIMPs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
dialysis-dependent
chronic kidney disease patients with hyperkalaemia and dialysis-dependent
干预措施: Lokelma® 5 g/45mL water (Drug)
dialysis-dependent
chronic kidney disease patients with hyperkalaemia and dialysis-dependent
干预措施: Calcium Polystyrene Sulphonate 15g/60 mL water (Drug)
dialysis-dependent
chronic kidney disease patients with hyperkalaemia and dialysis-dependent
干预措施: Veltassa® 8,4 g/80mL water (Drug)
dialysis-dependent
chronic kidney disease patients with hyperkalaemia and dialysis-dependent
干预措施: Sodium Polystyrene Sulphonate 15g/60 mL water (Drug)
non-dialysis-dependent
chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent
干预措施: Calcium Polystyrene Sulphonate 15g/60 mL water (Drug)
non-dialysis-dependent
chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent
干预措施: Lokelma® 10 g/45 mL water (Drug)
non-dialysis-dependent
chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent
干预措施: Veltassa® 8,4 g/80mL water (Drug)
non-dialysis-dependent
chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent
干预措施: Sodium Polystyrene Sulphonate 15g/60 mL water (Drug)
结局指标
主要结局
Difference in scores (0-40) for overall palatability of NIMPs
时间窗: 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)
次要结局
- Difference in scores (0-40) for overall palatability of NIMPs(Tasting visit (day 1))
- 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))
- 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))
- 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))
- 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))
- 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))