A Phase 3b Study to Reduce the Incidence of Pre-dialysis Hyperkalaemia
Research type
Research Study
Full title
A phase 3b, multicenter, prospective, randomized, double blind, placebo-controlled study to reduce the incidence of pre-dialysis hyperkalemia with Sodium Zirconium Cyclosilicate (DIALIZE)
IRAS ID
233847
Contact name
Sunil Bhandari
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-003029-14
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
The aim of this research study is to find an effective treatment for abnormally high potassium in the blood (called hyperkalaemia) in patients undergoing dialysis. Hyperkalaemia may adversely impact the function of the nerves and muscles, heart and digestive tract.
AstraZeneca is doing this research to find out if an experimental medication called Sodium Zirconium Cyclosilicate (or ZS) could be effective and safe when used to treat abnormally high concentrations of potassium in the blood. ZS is not yet approved by any Health Authority, such as the United States Food and Drug Administration (FDA) or European Medicines Agency (EMA).
Around 180 participants from 4 countries worldwide will participate.
The research study will go on until approximately the end of 2018.
Eligible patients: Women and men aged 18 years or above at the start of the study. Patients must have been having dialysis 3 times a week for the treatment of end-stage renal disease for at least 3 months
Total number of visits and total time in the study: 16 visits will occur over a 12 week period. This study consists of a 1-week screening period to decide if a patient is suitable to take part in the study. If yes, then the patient will enter an 8-week treatment period, when he/she will continue with their usual dialysis. On non-dialysis days the patient will take the study medication at home. ZS is a powder that will be made up by the patient into a drink with water. After the last dose of the drug, the patient will be followed up for the next 2 weeks. In general, the order of the assessments undertaken during the visit should match the site’s management of dialysis patients. Some procedures will take place more often to check the patient’s safety such as blood sampling, ECG (this procedure records the electronical signals in your heart) and some other non-invasive assessmentssuch as weight measurement and blood pressure measurement.
The study’s primary benefit for patients is expected to be the maintenance of normal potassium levels including the relief of associated signs and symptoms and an improved quality of life.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0377
Date of REC Opinion
9 Feb 2018
REC opinion
Further Information Favourable Opinion