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
Venkat Chintapalli
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-003527-14
Clinicaltrials.gov Identifier
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.Summary of results
The study was to learn if sodium zirconium cyclosilicate (SZC, the trial drug) helps people with chronic kidney disease (CKD) and high blood potassium (hyperkalemia) who are in the hospital.
This was a “Phase 4” trial. Researchers already did trials that showed SZC worked for many of the people with CKD and hyperkalemia who were in those trials. In this trial, the researchers wanted to find out more about how SZC works in participants who are in the hospital for CKD and hyperkalemia, and after they go home from the hospital.
This trial included 174 participants, ages 18 years or older. Each participant was in the trial for up to between 6 and 7 months. The trial started in March 2022 and ended in December 2024.
All the participants in this trial took SZC while they were still in the hospital. After they went home from the hospital, the participants took either SZC or “standard of care” treatment. “Standard of care” means the treatment that the medical community thinks is appropriate and widely accepted for a condition.
Overall, the researchers found that there were some differences between the groups. But, the differences were too small for the researchers to conclude if SZC affected the level of potassium in the participants’ blood. To answer this question, the researchers measured the levels of potassium in the participants’ blood. They counted how many participants had a normal level after 6 months of taking their trial treatment at home after leaving the hospital.
This meant the amount of potassium in their blood needed to be between 3.5 and 5.0 millimoles per liter (mmol/L). The researchers found that the number of participants in each group with normal levels of potassium in their blood was:
30.9% of participants taking SZC. This was 21 out of 68 participants.
36.2% of participants taking standard of care treatment. This was 25 out of 69 participants.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