Chronic Kidney Disease + Hyperkalaemia +/- Heart FailureAPPETIZENCT04566653
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
An observational study of Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure, run by AstraZeneca at 18 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
- What is being tested?
- Calcium Polystyrene Sulphonate 15g/60 mL water, Lokelma® 5 g/45mL water and Lokelma® 10 g/45 mL water
- How many people
- 147 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 23 Oct 2020to 12 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dialysis and non-dialysis CKD and HK
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Canada4 sites
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Québec, Quebec, G1L 3L5
Research Site
Toronto, Ontario, M5G 2C4
Spain4 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 8035
Research Site
Córdoba, 14004
Research Site
Madrid, 28031
France3 sites
Research Site
Amiens, 80054
Research Site
Boulogne-Billancourt, 92104
Research Site
Nice, 06000
Italy3 sites
Research Site
Genova, 16132
Research Site
Parma
Research Site
Pavia, 27100
United States2 sites
Research Site
Temple Terrace, Florida, 33637
Research Site
West Palm Beach, Florida, 33411
About this study
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).
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.
Read the 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.
- Being tested
- 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
- Keywords
- palatability, Lokelma, hyperkalaemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Polystyrene Sulphonate 15g/60 mL waterDrug
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
Lokelma® 5 g/45mL waterDrug
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
Lokelma® 10 g/45 mL waterDrug
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
Veltassa® 8,4 g/80mL waterDrug
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
Sodium Polystyrene Sulphonate 15g/60 mL waterDrug
K+ binder, not for treatment but for tasting (sip-and-spit taste test)
| Study group | Role | What they receive |
|---|---|---|
| dialysis-dependent | chronic kidney disease patients with hyperkalaemia and dialysis-dependent Receives: Drug: Calcium Polystyrene Sulphonate 15g/60 mL water; Drug: Lokelma® 5 g/45mL water; Drug: Veltassa® 8,4 g/80mL water; Drug: Sodium Polystyrene Sulphonate 15g/60 mL water | |
| non-dialysis-dependent | chronic kidney disease patients with hyperkalaemia and non-dialysis-dependent Receives: Drug: Calcium Polystyrene Sulphonate 15g/60 mL water; Drug: Lokelma® 10 g/45 mL water; Drug: Veltassa® 8,4 g/80mL water; Drug: Sodium Polystyrene Sulphonate 15g/60 mL water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in scores (0-40) for overall palatability of NIMPs
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)
Measured: Tasting visit (day 1)
Secondary outcomes (8)
Difference in scores (0-40) for overall palatability of NIMPs
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
Measured: Tasting visit (day 1)
Difference in scores (0-40) for overall palatability of NIMPs
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 European Union (EU)
Measured: 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
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
Measured: 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
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
Measured: 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
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 the EU
Measured: 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
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)
Measured: 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
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
Measured: 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
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
Measured: Tasting visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start23 Oct 2020
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease + Hyperkalaemia +/- Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc, Calyx, ERT: Clinical Trial Technology Solutions, Medidata Solutions
- Responsible party
- Sponsor
- Investigators
- Eric Wittbrodt, PharmD, MPH, Study director, AstraZeneca, Biopharmaceuticals Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566653
- Sponsor's protocol ID
- D9480C00016
- Acronym
- APPETIZE
- Status last verified
- Nov 2023
- First submitted
- 31 Jul 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
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.
PubMed 29177463Laureati 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.
PubMed 31377791Noel 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.
PubMed 31180477Zann 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.
PubMed 28919716Sondergaard H. Patient Involvement in the Design of an Innovative Clinical Study to Compare the Palatability of Anti-Hyperkalemia Medications. Patient Prefer Adherence. 2024 May 31;18:1059-1064. doi: 10.2147/PPA.S445399. eCollection 2024.
PubMed 38835400Wheeler DC, Sondergaard H, Gwynn C, Hedman K, Hedberg J, Allum A, Chung HL, Nagard M, Stjernlof G, Wittbrodt E, Kim J, Morris J. Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study. BMJ Open. 2024 Feb 21;14(2):e074954. doi: 10.1136/bmjopen-2023-074954.
PubMed 38387989
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04566653
- Acronym / sponsor ID
- APPETIZE / D9480C00016
- Keywords
- palatability, Lokelma, hyperkalaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc, Calyx, ERT: Clinical Trial Technology Solutions, Medidata Solutions
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dialysis-dependent | – | Drug: Calcium Polystyrene Sulphonate 15g/60 mL water, Drug: Lokelma® 5 g/45mL water, Drug: Veltassa® 8,4 g/80mL water, Drug: Sodium Polystyrene Sulphonate 15g/60 mL waterchronic kidney disease patients with hyperkalaemia and dialysis-dependent |
| non-dialysis-dependent | – | Drug: Calcium Polystyrene Sulphonate 15g/60 mL water, Drug: Lokelma® 10 g/45 mL water, Drug: Veltassa® 8,4 g/80mL water, Drug: Sodium Polystyrene Sulphonate 15g/60 mL waterchronic kidney disease patients with hyperkalaemia and non-dialysis-dependent |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dialysis and non-dialysis CKD and HK
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Polystyrene Sulphonate 15g/60 mL waterK+ binder, not for treatment but for tasting (sip-and-spit taste test) | Drug | dialysis-dependent, non-dialysis-dependent |
| Lokelma® 5 g/45mL waterK+ binder, not for treatment but for tasting (sip-and-spit taste test) | Drug | dialysis-dependent |
| Lokelma® 10 g/45 mL waterK+ binder, not for treatment but for tasting (sip-and-spit taste test) | Drug | non-dialysis-dependent |
| Veltassa® 8,4 g/80mL waterK+ binder, not for treatment but for tasting (sip-and-spit taste test) | Drug | dialysis-dependent, non-dialysis-dependent |
| Sodium Polystyrene Sulphonate 15g/60 mL waterK+ binder, not for treatment but for tasting (sip-and-spit taste test) | Drug | dialysis-dependent, non-dialysis-dependent |
Primary outcome
Difference in scores (0-40) for overall palatability of NIMPs
Time frame: 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)
8 secondary outcomes
Difference in scores (0-40) for overall palatability of NIMPs
Time frame: Tasting visit (day 1)
Difference in scores (0-40) for overall palatability of NIMPs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Tasting visit (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 29177463Thomsen 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.
- Background: PubMed 31377791Laureati 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.
- Background: PubMed 31180477Noel 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.
- Background: PubMed 28919716Zann 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.
- Derived from this study: PubMed 38835400Sondergaard H. Patient Involvement in the Design of an Innovative Clinical Study to Compare the Palatability of Anti-Hyperkalemia Medications. Patient Prefer Adherence. 2024 May 31;18:1059-1064. doi: 10.2147/PPA.S445399. eCollection 2024.
- Derived from this study: PubMed 38387989Wheeler DC, Sondergaard H, Gwynn C, Hedman K, Hedberg J, Allum A, Chung HL, Nagard M, Stjernlof G, Wittbrodt E, Kim J, Morris J. Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study. BMJ Open. 2024 Feb 21;14(2):e074954. doi: 10.1136/bmjopen-2023-074954.
- AdSAM Emotional Response Modelling website. AdSAM Measure.Link provided by the sponsor.
- Ingelfinger JR. A new era for the treatment of hyperkalemia? N Engl J Med \[Internet\]. 2015 Jan 15;372(3):275-7.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Guinard JX, Mazzucchelli R. The sensory perception of texture and mouthfeel. Trends Food Sci Technol. 1996;7(7):213-9Link provided by the sponsor.
- CSR synopsis redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Wittbrodt, PharmD, MPH study director
AstraZeneca, Biopharmaceuticals Medical
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure, run by AstraZeneca at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada, Spain, France, Italy, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in scores (0-40) for overall palatability of NIMPs (time frame: Tasting visit (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566653, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.