Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia

NCT04566653 | Completed

• 1 other identifier: D9480C00016
• Study Type: observational
• Target: 147
• Locations: 6 countries
• Sites: 18

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.

Conditions

Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure

Keywords

palatability; Lokelma; hyperkalaemia

Outcome Measures

Primary Outcomes (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 United States (US)

  Tasting visit (day 1)

Secondary Outcomes (8)

• Difference in scores (0-40) for overall palatability of NIMPs

  Tasting visit (day 1)

• 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)

• 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)

Other Outcomes (7)

• See primary and secondary endpoints

  Tasting visit (day 1)

• See primary and secondary endpoints

  Tasting visit (day 1)

• Categories or combinations based on Appeal of each attribute (taste, texture, smell, and mouthfeel)

  Tasting visit (day 1)

Study Arms (2)

dialysis-dependent

chronic kidney disease patients with hyperkalaemia and 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 water

non-dialysis-dependent

chronic kidney disease patients with hyperkalaemia and 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 water

Interventions

Calcium Polystyrene Sulphonate 15g/60 mL water DRUG

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

dialysis-dependent; non-dialysis-dependent

Lokelma® 5 g/45mL water DRUG

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

dialysis-dependent

Lokelma® 10 g/45 mL water DRUG

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

non-dialysis-dependent

Veltassa® 8,4 g/80mL water DRUG

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

dialysis-dependent; non-dialysis-dependent

Sodium Polystyrene Sulphonate 15g/60 mL water DRUG

K+ binder, not for treatment but for tasting (sip-and-spit taste test)

dialysis-dependent; non-dialysis-dependent

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dialysis and non-dialysis CKD and HK

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Labcorp Corporation of America Holdings, Inc: collaborator
• Calyx: collaborator
• ERT: Clinical Trial Technology Solutions: collaborator
• Medidata Solutions: collaborator

Study Sites (18)

Research Site

Temple Terrace, Florida, 33637, United States

Location

Research Site

West Palm Beach, Florida, 33411, United States

Location

Research Site

Toronto, Ontario, M5G 2C4, Canada

Location

Research Site

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Research Site

Montreal, Quebec, H1T 2M4, Canada

Location

Research Site

Québec, Quebec, G1L 3L5, Canada

Location

Research Site

Amiens, 80054, France

Location

Research Site

Boulogne-Billancourt, 92104, France

Location

Research Site

Nice, 06000, France

Location

Research Site

Genova, 16132, Italy

Location

Research Site

Parma, Italy

Location

Research Site

Pavia, 27100, Italy

Location

Research Site

A Coruña, 15006, Spain

Location

Research Site

Barcelona, 8035, Spain

Location

Research Site

Córdoba, 14004, Spain

Location

Research Site

Madrid, 28031, Spain

Location

Research Site

Eskilstuna, 631 88, Sweden

Location

Research Site

Stockholm, 182 88, Sweden

Location

Related Publications (6)

• 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.

  PMID: 29177463 BACKGROUND

• 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.

  PMID: 31377791 BACKGROUND

• 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.

  PMID: 31180477 BACKGROUND

• 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.

  PMID: 28919716 BACKGROUND

• Sondergaard 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.

  PMID: 38835400 DERIVED

• Wheeler 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.

  PMID: 38387989 DERIVED

Related Links

• AdSAM Emotional Response Modelling website. AdSAM Measure.
• Ingelfinger JR. A new era for the treatment of hyperkalemia? N Engl J Med \[Internet\]. 2015 Jan 15;372(3):275-7.
• 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
• CSR synopsis redacted

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Interventions

polystyrene sulfonic acid; Water; sodium zirconium cyclosilicate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Eric Wittbrodt, PharmD, MPH

  AstraZeneca, Biopharmaceuticals Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: September 28, 2020
• Study Start: October 23, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CA (4); SE (2); US (2); IT (3); FR (3); ES (4)