CONTINUITY

  • Research type

    Research Study

  • Full title

    An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) after Discharge in Participants with Chronic Kidney Disease treated for Hyperkalaemia

  • IRAS ID

    1004368

  • Contact name

    Anita Osborne

  • Contact email

    anita.osborne@astrazeneca.com

  • Sponsor organisation

    AstraZeneca AB

  • Eudract number

    2021-003527-14

  • Clinicaltrials.gov Identifier

    NCT05347693

  • Research summary

    The purpose of this study is to learn more about the medication, sodium zirconium cyclosilicate (SZC; Lokelma®). We want to better understand its safety and effectiveness in maintaining blood potassium levels as normal as possible in patients with chronic kidney disease that have been discharged from the hospital after having been treated for hyperkalaemia (high blood potassium levels) while in the hospital. We will compare a group of patients taking SZC, with a group of patients not receiving SZC that are managed with standard of care (the usual way of managing the condition).
    SZC belongs to a class of medications called potassium binders, which are used to treat hyperkalaemia (high levels of potassium in the blood). It works by binding potassium in the gastrointestinal tract and eliminating it in the faeces.
    The study drug is a powder that is mixed in water and swallowed.
    Some parts of this study are experimental which means “they have not been fully tested”. SZC is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, for the treatment of hyperkalaemia.
    People who have chronic kidney disease and are receiving treatment for high potassium levels in their blood (hyperkalaemia) will be invited to take part and will be recruited at participating hospitals. Participants will be in the study for approximately 6.5 and a half months.
    Before anyone can start the study they will undergo a series of tests. This is called screening. If the screening criteria is met they will be included in the study.
    This study includes 3 phases once screening is completed: one phase at the hospital, a second phase at home, and a third follow-up phase, also at home. There will be 4 on-site visits and 4 telephone visits. Additional unscheduled visits can occur if patients are not feeling well or experience any side effects, or if their doctor thinks they are needed.
    The study is funded by AstraZeneca AB.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    22/LO/0020

  • Date of REC Opinion

    2 Feb 2022

  • REC opinion

    Further Information Favourable Opinion