A phase 3 study to reduce the incidence of arrhythmia-related events in dialysis patients

• Research type

  Research Study

• Full title

  An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis with Recurrent Hyperkalemia (DIALIZE-Outcomes)

• IRAS ID

  1003620

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2020-005561-14

• Research summary

  The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia (high levels of potassium in the blood).

  This is an event-driven study, which means that duration depends upon predetermined number of 770 events (sudden cardiac death, stroke, or hospitalization/intervention/ Emergency Department (ED) visit due to arrhythmias) that occur in the overall group of patients who join the study. The anticipated recruitment period is planned to be 15 months. The anticipated average treatment period is 25 months. About 2300 people will take part in this study in approximately 20 countries.

  Patients with end-stage renal disease (ESRD) on hemodialysis have an increased risk of abnormal heart rhythms that can increase the chances of sudden cardiac death and stroke. Abnormally high levels of potassium before dialysis and the rapid shifts in blood potassium levels that occur during dialysis may worsen or trigger these cardiac arrhythmias.

  The effect of SZC will be compared to placebo. The patient is randomly assigned a study treatment and has a 50% chance of receiving SZC and a 50% chance of receiving placebo. This is a double-blind study, which means that patient and study doctor do not know which study drug (SZC or placebo) patient will take.

  The study consists of screening phase and treatment phase. The screening includes 3 visits over a 3-week period and the treatment phase includes one visit/interaction every 3 months during the hemodialysis session.

  The study drug will administered orally once daily on non-dialysis days starting at a dose of 5 g once daily. The dose may be increased weekly in amounts of 5 g per day at a time to a maximum dose of 15 g once daily on non-dialysis days, depending on the current potassium value as measured at the local laboratory.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0211

• Date of REC Opinion

  12 May 2021

• REC opinion

  Further Information Favourable Opinion